Cited by 41Cancer survivorship and careArt Therapy and Mental HealthFrailty in Older Adults

Cancer and Aging: Reflections for Elders (CARE): A pilot randomized controlled trial of a psychotherapy intervention for older adults with cancer

Open access
Nelson, Christian J., Saracino, Rebecca M., Roth, Andrew J., Harvey, Elizabeth, Martin, Anne, Moore, Mark, Marcone, Dana, Poppito, Shannon R. +1 more·2019·Psycho-Oncology

Abstract

Objective: Cancer and Aging: Reflections for Elders (CARE) is a novel, telephone-delivered intervention designed to alleviate distress in older cancer patients. This pilot randomized controlled trial tested the feasibility and initial efficacy of CARE, drawing from age-appropriate developmental themes and well-established coping theory. Method: Eligible patients were ≥70 years old; ≥6 months post-diagnosis of lung, prostate, breast, lymphoma, or gynecological cancer; on active cancer treatment or within 6 months of ending cancer treatment; and had elevated scores on the Distress Thermometer (≥4) or Hospital Anxiety and Depression Scale (≥6). Participants completed five sessions of psychotherapy over 7 weeks with assessments at study entry, post-intervention, and 2 months post-intervention. Primary outcomes were feasibility and initial efficacy on anxiety and depression; secondary outcomes included demoralization, coping, loneliness, and spiritual well-being. Results: Fifty-nine participants were randomized to either the CARE arm (n = 31) or the enhanced Social Work Control arm (n = 28). The intervention was feasible and tolerable, meeting a priori criteria for rates of eligibility, acceptance, retention, assessment, and treatment fidelity. Upon completion of the intervention, participants in the CARE arm demonstrated lower mean depression scores (d = 0.58 [CI: 0.04-1.12], P = 0.01) and trended towards increased coping-planning (d = 0.30 [CI: −0.83 to 0.24], P = 0.18). Promising trends in anxiety (d = 0.41 [CI: −0.17 to 0.98], P = 0.10) emerged at 2 months post-intervention; effects for coping-planning dissipated. Conclusion: These pilot data suggest the CARE intervention is feasibly delivered, potentially impacts important psychosocial variables, and is accessible for older, frail patients with cancer. Future research will evaluate this intervention on a larger scale. © 2018 John Wiley & Sons, Ltd.

Integrity signals

Registry

Crossref · 10.1002/pon.4907

Cites

35 of 35 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

1 of 19 cited sources checked · 1 supported · 0 flagged

  • Findingown data

    The trial randomized 59 participants (CARE n=31; ESWC n=28).

    “Sixty-eight participants consented to the study and of those, 59 were randomized (CARE n = 31; ESWC n = 28).”
    Quote in the paperSubstantial claim
  • Findingown data

    At 4 months, effects on coping-planning did not persist (d=0.04 [CI: -0.61 to 0.54], P=0.88).

    “The effects on coping-planning did not persist (d = 0.04 [CI: –0.61 to 0.54], P = 0.88)”
    Quote in the paperNot a substantial claim
  • Findingown data

    At 2 months post-intervention, the CARE arm had lower mean total HADS scores than ESWC (d=0.46 [CI: -0.07 to 0.99], P=0.02).

    “At the 2-month assessment (Table 2), the CARE arm reported lower mean total HADS scores compared with the ESWC arm (d = 0.46 [CI: –0.07 to 0.99], P = 0.02)”
    Quote in the paperSubstantial claim
  • Findingown data

    Of 541 patients who met initial eligibility and were contacted, 118 (22%) agreed to be screened for distress and participate.

    “In total, 541 patients met initial eligibility criteria and were contacted about the study. Of those, 118 (22%) agreed to be screened for distress and participate in the study.”
    Quote in the paperSubstantial claim
  • Findingown data

    At 4 months, the CARE arm trended towards lower anxiety scores than ESWC (d=0.41 [CI: -0.25 to 0.81], P=0.10).

    “The CARE arm trended towards reporting lower anxiety scores compared with ESWC (d = 0.41 [CI: –0.25 to 0.81], P = 0.10)”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 17
  • May combine two claims. 24
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Fidelity of 80 to 100% was considered high fidelity.

    “fidelity of 80 to 100% will be considered high fidelity.30”
    Quote in the paperNot a substantial claim1 of 1 sources checked
  • May combine two claims.

    Findingown data

    At 4 months, the CARE group continued to trend towards gains on main outcome variables; the total HADS effect remained consistent (d=0.42 [CI: -0.16 to 0.99], P=0.09).

    “At 4 months (2 months without either intervention, Table 2), the CARE group continued to trend towards making gains on main outcome variables. The effect on total HADS scores remained consistent (d = 0.42 [CI: –0.16 to 0.99], P = 0.09).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    81.4% (48/59) completed the full number of sessions and final study assessment, meeting the a priori 80% benchmark for adequate retention and assessment.

    “Thus, 81.4% (48 out of 59) of participants completed the full number of sessions and the final study assessment, indicating adequate retention and assessment per our a priori cut-off of 80% as a benchmark for feasibility.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Of those who agreed to be screened, 58% (68/118) met distress eligibility and were offered participation; all 68 consented and enrolled.

    “In total, 68 patients (13% of those who met initial eligibility criteria and 58% of those who agreed to be screened) met distress eligibility and were offered participation in the study. All 68 individuals were consented and enrolled, reflecting a high acceptance rate among those who met both stages of eligibility.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Treatment fidelity was 88.5% or higher for all sessions (88.5-94.6%), exceeding the 80% threshold for high fidelity.

    “Treatment fidelity was 88.5% or higher for all sessions (88.5–94.6%), again exceeding our threshold of 80% as an indication of high fidelity.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    The effect remained consistent for total HADS scores and strengthened for HADS Anxiety, disheartenment, and meaning scores.

    “While this occurred with HADS depression scores, the effect remained consistent for total HADS scores and strengthened for HADS Anxiety, disheartenment, and meaning scores.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    The sample had a mean age of 76 (SD=4), was 53% female, 90% Caucasian, and 81% had a college degree.

    “The sample was approximately evenly split by gender (53% female; n = 33) with a mean age of 76 (SD = 4). Participants were primarily Caucasian (90%; n = 56) and well-educated (81% had a college degree; n = 50).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Of 31 CARE participants, 3 did not complete all sessions (89.3% completion); of 28 ESWC participants, 1 did not complete all sessions (96.4%).

    “Of the 31 participants who started the CARE intervention, three participants did not complete all sessions (89.3%). In the ESWC arm, 28 participants initiated the treatment and 1 did not complete all sessions (96.4%).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    At 4 months, effect sizes increased for disheartenment (d=0.33 [CI: -0.25 to 0.91], P=0.09) and meaning (d=0.48 [CI: -1.06 to 0.11], P=0.04).

    “Effect sizes (d) also increased for disheart- enment (d = 0.33 [CI: –0.25 to 0.91], P = 0.09) and meaning (d = 0.48 [CI: –1.06 to 0.11], P = 0.04), indicating greater improvement for participants in the CARE arm across constructs.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingreasoning

    The intervention was delivered by those with master's level counseling degrees and proved possible in this pilot study.

    “It was therefore delivered by those with master’s level counseling degrees and proved possible in this pilot study.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    At 2 months, the CARE arm showed non-significant trends for reduced loneliness, disheartenment, sense of failure, increased meaning, and improved coping-planning.

    “The CARE arm, compared with ESWC, demonstrated promising trends, with small effects for reduced loneliness (d = 0.19 [CI: –0.34 to 0.72], P = 0.21), disheartenment (d = 0.28 [CI: –0.25 to 0.08], P = 0.12), and sense of failure (d = 0.26 [CI: –0.27 to 0.79], P = 0.19), increased meaning (d = 0.22 [CI: –0.75 to 0.31], P = 0.27), and improved coping-planning (d = 0.30 [CI: –0.83 to 0.24], P = 0.18),”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    The study utilized several different therapists, all of whom achieved high levels of treatment fidelity when rated by independent coders.

    “These aims were achieved as the study utilized several different therapists, all of whom achieved high levels of treatment fidelity when rated by independent coders.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Study design and conductreasoning

    The study was not powered to determine significant differences between intervention and control groups but was powered to determine feasibility and initial efficacy.

    “Given the pilot nature of the data, the study was not powered to determine significant differences between the intervention and control groups but was powered to determine feasibility and initial efficacy.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The study did not explicitly screen for hearing impairments.

    “Although all participants completed pre-randomization and all subsequent study measures over the phone, we did not explicitly screen for hearing impairments”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    Reappraisal is a critical element of adaptive coping and is identified as a core mechanism of the CARE intervention.

    “The process of reappraisal, in which an individual revises the meaning of events in ways that are more consistent with their new situation, is a critical element of adaptive coping, and we identify it as a core mechanism of the CARE intervention.17”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [17] source
  • Classified as probably not a substantial claim.

    Premisecitation

    The study adopted Leon, Davis, and Kraemer's (2011) criteria for demonstrating feasibility in a pilot study.

    “We adopted Leon, Davis, and Kraemer’s (2011) criteria for demonstrating feasibility in a pilot study.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Leon, Davis, and Kraemer’s (2011)

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • May combine two claims.

    Interpretationown data

    CARE demonstrated promising trends in psychosocial outcomes relative to ESWC, with reduced depression, anxiety, and demoralization.

    “CARE demonstrated promising trends in psychosocial outcomes relative to the ESWC, as CARE participants reported reduced depression, anxiety, and demoralization.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The Enhanced Social Work Control is an effective and proven control group.
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Treatment fidelity was rated by research assistants using a standardized adherence checklist for 60% of participants in each arm.

    “Research assistants rated fidelity utilizing a standardized adherence checklist form to evaluate sessions for a subset (60%) of participants in each arm”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The CARE intervention was developed with feedback from an expert panel of older adults with cancer and tested with a second group of older patients.

    “The structure and themes of CARE were originally presented to an expert panel of older adults with cancer. Over the course of seven meetings, the participants gave feedback on the relative salience and utility of intervention content. After the manual was revised with their feedback, the intervention was tested with a second group of older patients in a group format.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    Older adults who do not achieve ego integrity are more likely to experience despair and disdain and have fewer resources for coping with stressors like cancer.

    “According to the theory, older adults who do not achieve ego integrity are more likely to experience despair and disdain and have fewer resources for coping with stressors like cancer.20–22”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [20]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [21]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [22]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S4 (based).

    Premisenone given

    CARE is the only telephone-facilitated psychotherapy intervention specifically designed for older cancer patients with input of older people with cancer.

    “CARE is the only telephone-facilitated psychotherapy intervention specifically designed for older cancer patients with the input of older people with cancer.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationown data

    The sample was predominately White and college-educated, limiting generalizability of effects and patient satisfaction.

    “First, our sample was predominately White and college-educated. Thus, the generaliz- ability of the effects and of patient satisfaction with the intervention may be limited.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    CARE therapists received in-depth training and weekly supervision; ESWC had weekly supervision.

    “The CARE arm received in-depth training: (1) in-person review of the manual with study investigators, (2) observation of several cases, and (3) conducting 1 to 2 “mock” cases with study investigators. CARE therapists received weekly, hour-long ongoing supervision throughout the course of the study. For ESWC, there was weekly supervision facilitated by the primary social worker at MSK.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Questionnaires were completed over the phone with a research assistant blinded to group assignment.

    “The questionnaires were completed over the phone with a research assistant who was blinded to group assignment.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Premisecitation

    Older adults with anxiety or depression are likely to remain undiagnosed and thus often go untreated.

    “Unfortunately, older adults with anxiety or depression are likely to remain undiagnosed and thus often go untreated.9–11”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [9] source
    • cites [10] source
    • cites [11] source
  • Probably not a substantial claim: may not pass S4 (based).

    Premisereasoning

    CARE is the first psychotherapy intervention to incorporate developmental issues distinctive to older adults and the combined issues of aging and cancer.

    “With this solid foundation, it is also the first psychotherapy intervention to incorporate the developmental issues distinctive to older adults and the combined issues of aging and cancer.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    The benchmark for retention and assessment was 80%.

    “Our benchmark for retention and assessment is 80% such that if 80% of participants complete all sessions and assessments, then study feasibility will be demonstrated.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    The pilot data demonstrate benefits of a flexible, telephone-based approach as evidenced by low attrition and most participants completing all sessions.

    “The pilot data demonstrate the benefits of this flexible, telephone-based approach as evidenced by the low attrition rate in the CARE arm and the fact that most participants completed all sessions.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Interpretationreasoning

    Telephone recruitment may yield lower accrual but is a reasonable trade-off for accessing homebound or more physically frail older adults.

    “We also propose that the potential lower accrual rate achieved via telephone recruitment may be a reasonable trade-off for this population in terms of accessing homebound or more physically frail older adults”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S4 (based).

    Premisenone given

    To date, there are no psychotherapeutic interventions specifically designed to address the emotional distress of older cancer patients.

    “To date, there are no psychotherapeutic interventions specifically designed to address the emotional distress of older cancer patients.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    The study was approved by IRBs and registered at ClinicalTrials.gov #NCT00984321.

    “This study was approved by the MSK (protocol # 09–116) and Joan Karnell Cancer Center (protocol # 814950) Institutional Review Boards. This trial was registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT00984321.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisereasoning

    Prior interventions for older cancer patients were relatively small, lacked a theoretically driven intervention, and were not specifically tailored to developmental issues related to aging or the needs of older adults.

    “These are sound interventions with positive outcomes; however, these were relatively small studies, lacked a theoretically driven intervention, and were not specifically tailored to the developmental issues related to aging or the needs of older adults.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Randomization was stratified by cancer type and gender.

    “The randomization was stratified by cancer type (breast, prostate, lung, lymphoma, and gynecological) and gender by the MSK Office of Clinical Research Protocol Participation Registration system.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationown data

    Preliminary results indicate CARE has significant promise and warrants a larger scale RCT.

    “In sum, these preliminary results indicate that the CARE intervention has significant promise and warrants a larger scale RCT.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The Enhanced Social Work Control is an effective and proven control group.
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Several relevant variables, such as successful aging and wisdom, were not captured, which would allow analyses on the hypothesized change mechanism.

    “Finally, there were several relevant variables not captured in the data collected in this study, such as measures of successful aging and wisdom, which would allow”
    Quote in the paperNot a substantial claim
35 of 35
  • The paper relies on this without support.

    The Enhanced Social Work Control is currently considered standard of care.

    “The control condition (ESWC), which is currently considered standard of care, consisted of an initial telephone session with one of several social workers specializing in geriatrics”
  • The paper relies on this without support.

    The Enhanced Social Work Control is an effective and proven control group.

    “It is also important to note that the effects that were observed emerged when compared against an effective and proven control group that was run by experienced social workers in psycho-oncology.”
  • The paper relies on this without support.

    Clinicians cannot assure that mental health intervention can or will be feasible, effective, and safe.

    “But even if diagnosed correctly, clinicians cannot assure that mental health intervention can or will be feasible, effective, and safe.”
  • The paper relies on this without support.

    In psychosocial interventions, effects commonly decrease following the end of the intervention.

    “In psycho-social interventions, it is common for effects to decrease following the end of the intervention.”
4 of 4

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Study length is described as both 7 sessions and 5 sessions

    Minor

    One place says participants completed five sessions over 7 weeks, while another says the original format was 7 sessions and later the standard session number would be 5. These statements conflict about the intervention dosage used in the study.

  • Disheartenment effect lies outside its confidence interval

    Minor

    The reported effect of 0.28 exceeds its confidence interval's upper bound of 0.08.

  • Two-month active-coping effect lies outside its confidence interval

    Minor

    The reported effect of −0.28 is below its confidence interval's lower bound of −0.25.

  • Four-month active-coping effect lies outside its confidence interval

    Minor

    The reported effect of −0.43 is below its confidence interval's lower bound of −0.15.

  • Abstract and results give different anxiety confidence intervals

    Minor

    For the two-month post-intervention anxiety effect, the abstract and results report the same effect size and P value but different confidence intervals.

  • Marital-status counts exceed the randomized sample

    Minor

    The four marital-status counts sum to 62, although the paper says 59 participants were randomized.

    Reported 59 · recomputed 62

  • Planning effect lies outside its confidence interval

    Minor

    The reported effect of 0.30 exceeds its confidence interval's upper bound of 0.24.

7 of 7

Cites

Flagged first, then by citations

3 of the 38 references couldn’t be matched to a known paper.

Research works printed but not linked: 4

  1. Blank TO, 2003, How do men "make sense" of their prostate cancer?: age and treatment factors, Gerontologist, 43, 342
  2. Erikson E, 1950, Childhood and Society
  3. Erikson JM, 1997, The Life Cycle Completed: Erik H. Erikson
  4. Vaillant G, 2002, Aging Well

Cited by

Sorted by citations

Authors
Nelson, C. J., Saracino, R. M., Roth, A. J., Harvey, E., Martin, A., Moore, M., Marcone, D., Poppito, S. R., & Holland, J.
Affiliations
  • Memorial Sloan Kettering Cancer Center (US)
  • Pennsylvania Hospital (US)
  • Behavioral Health Oncology Service Charles A. Sammons Cancer Center Dallas Texas USA
Corresponding author
Nelson, Christian J.
Venue
Psycho-Oncology
Publisher
Wiley
Published
2018-11-07
Volume
28
Issue
1
Pages
39-47
ISSN
  • 1057-9249 (ISSN-L)
  • 1099-1611
OpenAlex
W2896684700
Cited by
41
References
38
Citations by year
2026: 5 · 2025: 6 · 2024: 5 · 2023: 6 · 2022: 7 · 2021: 6 · 2020: 3 · 2019: 3
FWCI
1.13
Type
journal article
Language
en
Open access
Locations
  • Psycho-Oncology (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • Cancer and Leukemia Group B Foundation
  • National Cancer Institute (P30 CA08748‐48, T32CA009461‐34)
Topics
  • Health Sciences › Medicine › Oncology › Cancer survivorship and care
  • Social Sciences › Arts and Humanities › Conservation › Art Therapy and Mental Health
  • Health Sciences › Medicine › Geriatrics and Gerontology › Frailty in Older Adults
Keywords
elderly cancer patients, psychotherapeutic interventions, telephone-delivered intervention, cancer-related distress, anxiety, depression, coping planning, demoralization, loneliness, spiritual well-being, feasibility, psychosocial support
MeSH terms
Adaptation, Psychological, Aged, Anxiety, Depression, Female, Humans, Male, Neoplasms, Patient Education as Topic, Pilot Projects, Psychotherapy, Outcome Assessment, Health Care

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