Original Article
Dyadic Psychosocial Intervention for Advanced Lung Cancer Patients and Their Family Caregivers: Results of a Randomized Pilot Trial Hoda Badr, PhD1; Cardinale B. Smith, MD, MSCR2,3; Nathan E. Goldstein, MD3,4; Jorge E. Gomez, MD3; and William H. Redd, PhD1
BACKGROUND: Advanced lung cancer (LC) patients and their families have reported low self-efficacy for self-care/caregiving and high rates of distress, yet few programs exist to address their supportive care needs during treatment. This pilot study examined the feasibility, acceptability, and preliminary efficacy of a 6-session, telephone-based dyadic psychosocial intervention that was developed for advanced LC patients and their caregivers. The program was grounded in self-determination theory (SDT), which emphasizes the importance of competence (self-efficacy), autonomy (sense of choice/volition), and relatedness (sense of belonging/connection) for psychological functioning. The primary outcomes were patient and caregiver psychological functioning (depression/anxiety) and caregiver burden. The secondary outcomes were the SDT constructs of competence, autonomy, and relatedness. METHODS: Thirty-nine advanced LC patients who were within 1 month of treatment initiation (baseline) and their caregivers (51% spouses/partners) completed surveys and were randomized to the intervention or usual medical care. Eight weeks after baseline, they completed follow-up surveys. RESULTS: Solid recruitment (60%) and low attrition rates demonstrated feasibility. Strong program evaluations (mean, 8.6/10) and homework completion rates (88%) supported acceptability. Participants receiving the intervention evidenced significant improvements (P 60 or 1 SD on the PROMIS measures). The proportion of participants scoring higher than 1 SD in the intervention and UMC groups who improved (ie, their T-score moved from 1 SD to 60 (11 SD), indicating high levels of depression. In 23% of dyads, both the patient and caregiver scored higher than 60. Also at baseline, 46% of patients and 69% of caregivers had 154
TABLE 2. Description of the Study Sample (39 Patient-Caregiver Dyads)
Sex, n (%) Male Female Age (y) Mean SD Range Race, white (non-Hispanic), n (%)a Employment status, n (%) Employed full-time Employed part-time Unemployed/retired Education, n (%) High school diploma or less At least some college College degree Caregiver relationship to the patient, n (%) Spouse/partner Son/daughter Other family member (ie, sibling, cousin, or parent) Married, n (%) Length of marriage (y) Mean SD Range Type of lung cancer, n (%) SCLC NSCLC Stage of cancer, n (%) Stage 3 NSCLC Stage 4 NSCLC Extensive-stage SCLC
Patients
Caregivers
10 (26) 29 (74)
12 (31) 27 (69)
68.17 10.30 38-87 33 (85)
51.10 10.24 35-70
6 (15) 9 (23) 24 (62)
14 (36) 16 (41) 9 (23)
5 (14) 15 (38) 19 (48)
2 (5) 13 (33) 24 (62)
20 (51) 12 (31) 7 (18) 23 (59) 36.20 8.70 18-51 6 (16) 33 (84) 10 (26) 23 (58) 6 (16)
Abbreviations: NSCLC, non–small cell lung cancer; SCLC, small cell lung cancer. a The race of the caregiver was not assessed.
PROMIS anxiety T-scores > 60, indicating high levels of anxiety. In 33% of dyads, both the patient and caregiver scored higher than 60. As Table 3 shows, all correlations were in the expected directions. The partial correlations for patient and caregiver depression and anxiety were not significant. Preliminary Efficacy
Means for the primary and secondary outcomes at T0 and T1 are presented in Table 4. Primary outcomes
At T1, there was a significant difference in depression (P < .0001), with the intervention group having lower mean scores (less depressive symptomatology) than the UMC group. The effect size for this difference was d 5 21.8, which is a large effect.31 There was also a significant main effect for role [F(1,73) 5 4.55, P 5 .04], Depression.
Cancer
January 1, 2015
Lung Cancer Dyadic Intervention/Badr et al
TABLE 3. Baseline Correlations (39 Patients and 39 Caregivers)a
1. 2. 3. 4. 5. 6.
Depression Anxiety Caregiver burden Autonomye Competence Relatedness
1
2
3
4
5
6
.30b .75c .47c 2.40d 2.38d 2.12
.69c .21 .35d .33d 2.37d 2.19
— — — 2.20 2.35d 2.27b
2.47c 2.39d — — .26b 2.01
2.60c 2.59c — .66c .46c .20
2.24 2.19 — .34d .21 .66c
a
Partial correlations between patients and caregivers are bolded and form a diagonal. Correlations for patients are above the diagonal. Correlations for caregivers are below the diagonal. P
Dyadic Psychosocial Intervention for Advanced Lung Cancer Patients and Their Family Caregivers: Results of a Randomized Pilot Trial Hoda Badr, PhD1; Cardinale B. Smith, MD, MSCR2,3; Nathan E. Goldstein, MD3,4; Jorge E. Gomez, MD3; and William H. Redd, PhD1
BACKGROUND: Advanced lung cancer (LC) patients and their families have reported low self-efficacy for self-care/caregiving and high rates of distress, yet few programs exist to address their supportive care needs during treatment. This pilot study examined the feasibility, acceptability, and preliminary efficacy of a 6-session, telephone-based dyadic psychosocial intervention that was developed for advanced LC patients and their caregivers. The program was grounded in self-determination theory (SDT), which emphasizes the importance of competence (self-efficacy), autonomy (sense of choice/volition), and relatedness (sense of belonging/connection) for psychological functioning. The primary outcomes were patient and caregiver psychological functioning (depression/anxiety) and caregiver burden. The secondary outcomes were the SDT constructs of competence, autonomy, and relatedness. METHODS: Thirty-nine advanced LC patients who were within 1 month of treatment initiation (baseline) and their caregivers (51% spouses/partners) completed surveys and were randomized to the intervention or usual medical care. Eight weeks after baseline, they completed follow-up surveys. RESULTS: Solid recruitment (60%) and low attrition rates demonstrated feasibility. Strong program evaluations (mean, 8.6/10) and homework completion rates (88%) supported acceptability. Participants receiving the intervention evidenced significant improvements (P 60 or 1 SD on the PROMIS measures). The proportion of participants scoring higher than 1 SD in the intervention and UMC groups who improved (ie, their T-score moved from 1 SD to 60 (11 SD), indicating high levels of depression. In 23% of dyads, both the patient and caregiver scored higher than 60. Also at baseline, 46% of patients and 69% of caregivers had 154
TABLE 2. Description of the Study Sample (39 Patient-Caregiver Dyads)
Sex, n (%) Male Female Age (y) Mean SD Range Race, white (non-Hispanic), n (%)a Employment status, n (%) Employed full-time Employed part-time Unemployed/retired Education, n (%) High school diploma or less At least some college College degree Caregiver relationship to the patient, n (%) Spouse/partner Son/daughter Other family member (ie, sibling, cousin, or parent) Married, n (%) Length of marriage (y) Mean SD Range Type of lung cancer, n (%) SCLC NSCLC Stage of cancer, n (%) Stage 3 NSCLC Stage 4 NSCLC Extensive-stage SCLC
Patients
Caregivers
10 (26) 29 (74)
12 (31) 27 (69)
68.17 10.30 38-87 33 (85)
51.10 10.24 35-70
6 (15) 9 (23) 24 (62)
14 (36) 16 (41) 9 (23)
5 (14) 15 (38) 19 (48)
2 (5) 13 (33) 24 (62)
20 (51) 12 (31) 7 (18) 23 (59) 36.20 8.70 18-51 6 (16) 33 (84) 10 (26) 23 (58) 6 (16)
Abbreviations: NSCLC, non–small cell lung cancer; SCLC, small cell lung cancer. a The race of the caregiver was not assessed.
PROMIS anxiety T-scores > 60, indicating high levels of anxiety. In 33% of dyads, both the patient and caregiver scored higher than 60. As Table 3 shows, all correlations were in the expected directions. The partial correlations for patient and caregiver depression and anxiety were not significant. Preliminary Efficacy
Means for the primary and secondary outcomes at T0 and T1 are presented in Table 4. Primary outcomes
At T1, there was a significant difference in depression (P < .0001), with the intervention group having lower mean scores (less depressive symptomatology) than the UMC group. The effect size for this difference was d 5 21.8, which is a large effect.31 There was also a significant main effect for role [F(1,73) 5 4.55, P 5 .04], Depression.
Cancer
January 1, 2015
Lung Cancer Dyadic Intervention/Badr et al
TABLE 3. Baseline Correlations (39 Patients and 39 Caregivers)a
1. 2. 3. 4. 5. 6.
Depression Anxiety Caregiver burden Autonomye Competence Relatedness
1
2
3
4
5
6
.30b .75c .47c 2.40d 2.38d 2.12
.69c .21 .35d .33d 2.37d 2.19
— — — 2.20 2.35d 2.27b
2.47c 2.39d — — .26b 2.01
2.60c 2.59c — .66c .46c .20
2.24 2.19 — .34d .21 .66c
a
Partial correlations between patients and caregivers are bolded and form a diagonal. Correlations for patients are above the diagonal. Correlations for caregivers are below the diagonal. P
