Multisite Randomized Controlled Trial of CareSTEPS: A Supportive Care Intervention for the Family Caregivers of Patients With Advanced Lung Cancer

May combine two claims.

Caregiver burden and poor mental health can adversely affect the caregiver's ability to provide quality care to the patient.

“This contributes to caregiver burden18 and poor mental health,19 which can adversely affect the caregiver’s ability to provide quality care to the patient.”

• cites [18] Wood, 2019, The humanistic burden of advanced non-small cell lung cancer (NSCLC) in Europe: a real-world survey linking patient clinical factors to patient and caregiver burden, Qual Life Res sourcePartly supported

  The Results (Humanistic burden on caregivers; page unavailable) report greater caregiver burden, activity impairment, and risk of depression as patients’ functional status declines. The paper does not assess whether caregiver burden or poor mental health reduces the quality of care provided to patients. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites [19] Cochrane, 2021, Variables associated with distress amongst informal caregivers of people with lung cancer: a systematic review of the literature, Psychooncology sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

T-scores of 60 or more on PROMIS indicate moderate depression/anxiety in need for further psychological evaluation.

“T-scores of 60 or more indicate moderate depression/anxiety in need for further psychological evaluation.31, 32, 33”

• cites [31]Not matched

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

• cites [32] Kroenke, 2020, Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials, J Affect Disord sourcePartly supported

  The Results section (page not available in our copy) identifies a PROMIS depression T-score of 60 as an approximate threshold for moderate depression, with 65 and 70 marking higher severity levels. The paper does not establish the same threshold for anxiety or say that a score of 60 or more requires further psychological evaluation; it discusses cut-points as aids to treatment decisions. (LLM, conf=0.88)

  Experimental — accuracy not yet measured
• cites [33] Cheng, 2023, Interpretation of PROMIS depression and anxiety measures compared with DSM-5 diagnostic criteria in musculoskeletal patients, JB JS Open Access sourcePartly supported

  The Outcome Measures section says a PROMIS Depression or Anxiety score of 60 is unfavorable, and the Conclusions recommend using the measures to identify patients who may benefit from further mental health evaluation. But the paper does not define ≥60 as the threshold for moderate depression or anxiety or say that everyone at that score needs evaluation; its optimal screening cutoffs in these musculoskeletal patients were ≥53 for depression and ≥59 for anxiety. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

May combine two claims.

Caregivers of patients with LC report feeling unprepared and lacking caregiving resources.

“Caregivers of patients with LC report feeling unprepared, lacking caregiving resources,11,12 having low self-efficacy for managing patient symptoms, experiencing significant emotional distress,13, 14, 15 and receiving minimal psychosocial care.6,16,17”

• cites [11] Murray, 2002, Dying of lung cancer or cardiac failure: prospective qualitative interview study of patients and their carers in the community, Br Med J sourcePartly supported

  In “Living with illness” (page not specified), a lung-cancer carer worries about not knowing what to do when death occurs, supporting the feeling of being unprepared. “Service provision” (page not specified) says carer support and other services were usually available, though misunderstandings sometimes prevented access. It does not establish that lung-cancer caregivers generally lacked caregiving resources. (LLM, conf=0.85)

  Experimental — accuracy not yet measured
• cites [12] Bakas, 2001, Caregiving tasks among family caregivers of patients with lung cancer, Oncol Nurs ForumNot checked — no full text of the source

May combine two claims.

The effect sizes for CareSTEPS are comparable to and exceed those reported in the broader literature on cancer caregivers.

“These effect sizes are comparable to and exceed those reported in the broader literature on cancer caregivers,21,40”

• cites [21] Chow, 2023, Interventions to improve outcomes for caregivers of patients with advanced cancer: a meta-analysis, J Natl Cancer Inst sourceSupported
• cites [40] Cheng, 2022, Effectiveness of psychoeducational interventions among caregivers of patients with cancer: a systematic review and meta-analysis, Int J Nurs Stud sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S2 (checkable).

If the goal of a trial is to see if an intervention is superior to existing practices, it must be compared with them.

“if the goal of a trial is to see if an intervention is superior to existing practices (in this case, UC), it must be compared with them.43”

• cites [43] Freedland, 2011, Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions, Psychosom Med sourceSupported

The quote only partly states this claim.

CareSTEPS reduced caregiver burden compared with usual care at 8-week follow-up, with effect size d = −0.37.

“Caregivers who received CareSTEPS reported improved psychological functioning and lower burden compared with those who received usual care, with effect sizes ranging from small to large (depression d = −0.55, anxiety d = −0.81, burden d = −0.37).”

Probably not a substantial claim: may not pass S3 (load-bearing).

412 patients were screened; 78 were excluded because they did not meet inclusion criteria, primarily owing to lack of a caregiver or inability to contact the caregiver.

“The CONSORT diagram (Fig. 1) shows that 412 patients were screened. Seventy-eight were excluded because they did not meet the inclusion criteria, primarily owing to the lack of a caregiver or the research team’s inability to contact the caregiver to determine interest and eligibility.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In most cases, missed sessions were caused by conflicting demands or poor patient health.

“In most cases, missed sessions were caused by conflicting demands or poor patient health.”

The quote only partly states this claim.

CareSTEPS reduced anxiety symptoms compared with usual care at 8-week follow-up, with effect size d = −0.81.

“Caregivers who received CareSTEPS reported improved psychological functioning and lower burden compared with those who received usual care, with effect sizes ranging from small to large (depression d = −0.55, anxiety d = −0.81, burden d = −0.37).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Refusals were primarily owing to a lack of caregiver interest or availability.

“Refusals were primarily owing to a lack of caregiver interest or availability.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Employed caregivers reported greater depression than those who were not employed.

“employed caregivers reported greater depression (M = 12.77, SD = 4.65) than those who were not employed (M = 11.35, SD = 4.46) (t = 1.97, p = 0.05)”

Probably not a substantial claim: may not pass S3 (load-bearing).

60 (34.5%) caregivers exceeded the cut-off for the PROMIS anxiety measure at baseline.

“27 (15.5%) and 60 (34.5%) caregivers exceeded the cut-offs for the PROMIS depression and anxiety measures, respectively”

Probably not a substantial claim: may not pass S3 (load-bearing).

27 (15.5%) caregivers exceeded the cut-off for the PROMIS depression measure at baseline.

“27 (15.5%) and 60 (34.5%) caregivers exceeded the cut-offs for the PROMIS depression and anxiety measures, respectively”

Probably not a substantial claim: may not pass S3 (load-bearing).

Spouses/partners reported greater caregiver burden than sons/daughters and other family members.

“spouses/partners (M = 15.69, SD = 8.40) reported greater caregiver burden than sons/daughters (M = 14.71, SD = 9.28) and other family members (M = 11.44, SD = 8.00) (F = 2.97, p = 0.05)”

Probably not a substantial claim: may not pass S3 (load-bearing).

Of 334 eligible caregivers, 187 (56%) consented.

“Of the 334 eligible caregivers, 187 (56%) consented.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In most cases, lack of follow-up completion was caused by the patient entering hospice/dying (n = 15 of 34; 44%), the caregiver being too busy (n = 10; 29%), or the patient's poor health/death.

“In most cases, the lack of follow-up completion was caused by the patient entering hospice/dying (n = 15 of 34; 44%), the caregiver being too busy (n = 10; 29%), or the patient’s poor health/death.”

The quote only partly states this claim.

CareSTEPS reduced depression symptoms compared with usual care at 8-week follow-up, with effect size d = −0.55.

“Caregivers who received CareSTEPS reported improved psychological functioning and lower burden compared with those who received usual care, with effect sizes ranging from small to large (depression d = −0.55, anxiety d = −0.81, burden d = −0.37).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Caregivers who lived with the patient reported greater caregiver burden than those who did not live with the patient.

“caregivers who lived with the patient reported greater caregiver burden (M = 15.69, SD = 8.60) than those who did not live with the patient (M = 11.78, SD = 8.28; t = 2.67, p = 0.01)”

May combine two claims.

The study had 67% attendance and 50% homework completion rates.

“Despite positive evaluations, the 67% attendance and 50% homework completion rates reveal that caregivers struggled to consistently participate in the multisession intervention.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Some caregivers suggested choosing modules that addressed their caregiving challenges rather than completing the program to improve relevance and effectiveness.

“Others suggested choosing modules that addressed their caregiving challenges rather than completing the program to improve relevance and effectiveness.”

May combine two claims.

The effect size for the depression difference was Cohen's d = -0.55, a medium effect.

“The effect size for this difference (Cohen’s d) was −0.55, which is a medium effect,39 with an observed power of 0.91.”

• cites [39] Cohen, 1988Not matched

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

May combine two claims.

For caregivers meeting PROMIS depression criteria at baseline (N = 27), 40% in UC improved versus 83.3% in CareSTEPS, a significant difference (p = 0.047).

“For caregivers meeting PROMIS depression criteria at baseline (N = 27), six of the 15 (40%) in UC improved versus 10 of the 12 (83.3%) in CareSTEPS, showing a significant difference (p = 0.047, Fisher’s exact test).”

May combine two claims.

The effect size for the caregiver burden difference was -0.37, a small to medium effect.

“The effect size was −0.37, which was a small to medium effect with an observed power of 0.91.”

May combine two claims.

The effect size for the anxiety difference was d = -0.81, a large effect.

“The effect size (d) was −0.81, which is a large effect, with an observed power of 0.99.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Most caregivers enjoyed their participation, but some wanted more personalized sessions.

“Most caregivers enjoyed their participation, but some wanted more personalized sessions.”

May combine two claims.

Participants liked the program's convenience, usefulness, and relevance and praised the interventionists.

“Table 4 reports that participants liked the program's convenience, usefulness, and relevance and praised the interventionists.”

Probably not a substantial claim: may not pass S3 (load-bearing).

No statistically significant gender-based differences in distress were discovered.

“though no statistically significant gender-based differences in distress were discovered.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The trial was approved by the Baylor College of Medicine Institutional Review Board and registered with clinicaltrials.gov (NCT02414672).

“This multisite, open-label, individually randomized trial, approved by the Baylor College of Medicine Institutional Review Board and registered with clinicaltrials.gov (NCT02414672) was conducted between 2015 and 2021.”

Classified as probably not a substantial claim.

Data analysts were blinded to group assignments.

“Nevertheless, to maintain the integrity of the study results, the data analysts were blinded to group assignments.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Model covariates were selected based on their association with study outcomes: continuous variables if significant at p < 0.05, categorical if mean differences significant at p < 0.05.

“Model covariates were selected on the basis of their association with the study outcomes. Continuous variables were included as covariates if they reported a significant association with the outcomes at a p value lower than 0.05. Similarly, categorical variables were incorporated as covariates when M differences in the outcomes were statistically significant (p < 0.05).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Internal consistency reliability (Cronbach's α) for caregiver burden was 0.90 at T1 and 0.91 at T2.

“Cronbach’s α scores, αT1 and αT2, were 0.90 and 0.91, respectively.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Randomization was stratified by histologic type, disease stage, and type of patient-caregiver relationship using a computer-generated schedule with random block sizes of two and four, maintaining a 1:1 allocation ratio within each stratum.

“Randomization was stratified by histologic type (NSCLC versus SCLC), disease stage (IIIB versus IV or advanced), and type of patient-caregiver relationship (spouse or partner versus other family members) using a computer-generated schedule with random block sizes of two and four, maintaining a 1:1 allocation ratio within each stratum.”

May combine two claims.

Most educational resources in palliative care are designed for patients, despite caregivers' preference for materials tailored to their specific needs.

“Likewise, most educational resources in palliative care are designed for patients, despite caregivers' preference for materials tailored to their specific needs.22,23”

• cites [22] Bucher, 2001, Problem-solving cancer care education for patients and caregivers, Cancer Pract sourceNot checked — no full text of the source
• cites [23] Thomas, 2015, The development and evaluation of a multimedia resource for family carers of patients receiving palliative care: a consumer-led project, Palliat Support Care sourceNot checked — no full text of the source

May combine two claims.

Thirteen consenting caregivers dropped out before returning to the baseline survey (passive refusal), leaving 174 who were randomized.

“Thirteen consenting caregivers dropped out before returning to the baseline survey (passive refusal), leaving 174 who were randomized (87 to CareSTEPS, 87 to UC).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Internal consistency reliability (Cronbach's α) for anxiety was 0.89 at T1 and 0.90 at T2.

“In this study, internal consistency reliability (Cronbach’s α) scores for depression, αT1 and αT2, were 0.90 and 0.91, respectively and the scores for anxiety, αT1 and αT2, were 0.89 and 0.90, respectively.”

Probably not a substantial claim: may not pass S3 (load-bearing).

On average, caregivers completed 2.5 homework assignments (range 0-5).

“On average, caregivers completed 2.5 homework assignments (range 0–5).”

Classified as probably not a substantial claim.

Self-Determination Theory holds that meeting people's needs for competence, autonomy, and relatedness is critical for psychological health and well-being.

“The program is grounded by Self-Determination Theory,29 which holds that meeting people’s needs for competence (self-efficacy), autonomy (choice and volition), and relatedness (belonging and connection) is critical for psychological health and well-being.”

• cites [29] Deci, 2000, The “what” and “why” of goal pursuits: human needs and the self-determination of behavior, Psychol Inq sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

Analyses of covariance were conducted with T1 scores as model covariates and T2 scores as outcomes.

“Analyses of covariance were conducted to assess the efficacy of CareSTEPS, with T1 scores as model covariates and T2 scores as outcomes.”

Classified as probably not a substantial claim.

Analyses used an intent-to-treat framework.

“An intent-to-treat framework was implemented, and a two-sided p value of less than 0.05 was considered significant.”

May combine two claims.

Internal consistency reliability (Cronbach's α) for depression was 0.90 at T1 and 0.91 at T2.

“In this study, internal consistency reliability (Cronbach’s α) scores for depression, αT1 and αT2, were 0.90 and 0.91, respectively and the scores for anxiety, αT1 and αT2, were 0.89 and 0.90, respectively.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Fidelity was assessed by rating a random subset of 25% of digitally recorded sessions by two trained coders using a fidelity checklist.

“For each interventionist, a random subset of 25% of digitally recorded sessions were rated for fidelity by two trained coders. The fidelity checklist assessed whether session topics were covered and whether in-session exercises and homework were completed.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Sample size recalculation was conducted after 100 caregivers had been randomized (50 per arm) using actual attrition rates rather than pretrial estimates and without examining treatment effects.

“A sample size recalculation was conducted after 100 caregivers had been randomized (50 in each arm) using actual attrition rates rather than pretrial estimates and without examining treatment effects.”

Classified as probably not a substantial claim.

Missing data were handled using multiple imputation methods.

“Missing data were handled using multiple imputation methods.”

Probably not a substantial claim: may not pass S2 (checkable).

The most important factor in selecting a control condition is how well it fits the purpose of the trial.

“Because the most important factor in selecting a control condition is how well it fits the purpose of the trial,44”

• cites [44] Wampold, 2001Not matched

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

Probably not a substantial claim: may not pass S3 (load-bearing).

The observed power for the caregiver burden difference was 0.91.

“The effect size was −0.37, which was a small to medium effect with an observed power of 0.91.”

Classified as probably not a substantial claim.

The observed improvements may have been due to nonspecific effects because CareSTEPS was compared to usual care rather than an attention control condition.

“Given that we compared CareSTEPS to UC rather than an attention control condition, it is possible that the observed improvements were due to nonspecific effects.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Table 3 reports estimated marginal means for the primary and secondary outcomes, controlling for caregiver employment status, type of patient-caregiver relationship, and whether or not the caregiver lived with the patient.

“Table 3 reports the estimated marginal Ms for the primary and secondary outcomes, controlling for caregiver employment status, type of patient-caregiver relationship, and whether or not the caregiver lived with the patient.”