Objective: Anxiety symptoms are common among cancer survivors. This study evaluated whether an acceptance-based group intervention delivered by social workers in community oncology clinics improved anxiety and related symptoms, and healthcare use, relative to enhanced usual care (EUC). Method: This multi-site trial included 135 survivors of various cancers with moderate to high anxiety about cancer/ survivorship, 1.5-24 months after treatment. Participants were randomized 1:1 to a 7-session acceptance and commitment therapy (ACT)-based group (Valued Living) or EUC (access to onsite supportive care plus resource list). Questionnaires were administered at baseline, 1, 2, 5, and 8 months post-randomization, diagnostic interviews at baseline, 2, and 8 months, and healthcare use tracked throughout. Outcomes included anxiety symptoms (primary), related symptoms, and healthcare use. Putative moderators included age, anxiety, and avoidance. Results: In intent-to-treat comparisons to EUC, Valued Living (VL) showed a nonsignificant pattern of greater improvement on anxiety symptoms ( p = .08), improved significantly more on cancer-related post-traumatic stress ( p = .002), fear of recurrence ( p = .003), and energy/fatigue ( p = .02), and missed significantly fewer medical appointments ( p < .05). Conditions improved similarly on depressive symptoms, sense of meaning, and most severe anxiety or depressive disorder. Effects were moderated: VL participants with higher baseline anxiety or avoidance (+1SD) improved more on anxiety, meaning ( p s ≤ .01), and disorder severity ( p = .05) than their EUC counterparts. Conclusions: An acceptance-based group intervention delivered in community oncology clinics enhanced psychological recovery and energy levels, and reduced missed medical appointments for anxious cancer survivors, with stronger effects for more distressed participants. Public Health SignificanceThis trial demonstrated that an acceptance and commitment therapy (ACT)-based group intervention for anxious cancer survivors, as delivered by clinical social workers in community cancer care clinics, accelerated psychological recovery and energy levels, and reduced missed medical appointments. The effects were stronger and broader for more anxious and avoidant participants, demonstrating that cancer survivors with more pronounced psychological symptoms benefitted most.
Background Oral anti-cancer treatments such as adjuvant endocrine therapies (AET) for breast cancer survivors are commonly used but adherence is a challenge. Few low-touch, scalable interventions exist to increase ET adherence. Purpose To evaluate the acceptability, feasibility, and initial efficacy of a low-touch, remotely-delivered values plus AET education intervention (REACH) to promote AET adherence. Methods A mixed-methods trial randomized 88 breast cancer survivors 1:1 to REACH or Education alone. Wisepill real-time electronic adherence monitoring tracked monthly AET adherence during a 1-month baseline through 6-month follow-up (FU) (primary outcome). Patient-reported outcomes were evaluated through 3- and 6-month FU (secondary). Multiple indices of intervention feasibility and acceptability were evaluated. Qualitative exit interviews (n = 38) further assessed participants’ perceptions of feasibility/acceptability and recommendations for intervention adaptation. Results The trial showed strong feasibility and acceptability, with an eligible-to-enrolled rate of 85%, 100% completion of the main intervention sessions, and “good” intervention satisfaction ratings on average. For Wisepill-assessed AET adherence, REACH outperformed Education for Month 1 of FU (p = .027) and not thereafter. Participants in REACH maintained high adherence until Month 4 of FU, whereas in Education, adherence declined significantly in Month 1. Conditions did not differ in self-reported adherence, positive affective attitudes, future intentions, or necessity beliefs. REACH trended toward less negative AET attitudes than Education at 3-month FU (p = .057) reflecting improvement in REACH (p = .004) but not Education (p = .809). Exploratory moderator analyses showed that average to highly positive baseline AET affective attitudes and oncologist-patient communication each predicted higher adherence following REACH than Education; low levels did not. Participants identified recommendations to strengthen the interventions. Conclusions REACH, a low-touch values intervention, showed good feasibility and acceptability, and initial promise in improving objectively-assessed AET adherence among breast cancer survivors (relative to education alone). Future research should target improving REACH’s tailoring and endurance.
BackgroundAnxiety is a common concern of cancer survivors during the transition from active cancer treatment to cancer survivorship (the re-entry phase). This paper presents the study protocol for a novel group-based behavioral intervention to improve mental health, well-being, and medical use outcomes among anxious cancer survivors at re-entry.Methods/DesignThis two-armed, prospective randomized controlled trial will randomize a minimum of 100 re-entry-phase cancer survivors with moderate to high anxiety to the intervention or a usual care control condition. The intervention is delivered in a group format over 7 weeks; content is based on Acceptance and Commitment Therapy (ACT), an acceptance, mindfulness, and values-based intervention. Participants will be recruited from community cancer care centers and the intervention will be led by the onsite clinical social workers. Participants will be assessed at baseline, mid-intervention, post-intervention, and 3- and 6-month follow-up. ACT participants will complete process measures before the beginning of group sessions 2, 4, and 6; all participants will complete the process measures during the regular assessments. The primary outcome is anxiety symptoms; secondary outcomes include anxiety disorder severity, fear of recurrence, depressive symptoms, cancer-related trauma symptoms, sense of life meaning, vitality/fatigue, and medical utilization.DiscussionThis clinical trial will provide valuable evidence regarding the efficacy of the group ACT intervention in community oncology settings.Trial registrationClinicaltrials.gov NCT02550925.
Objective: Acceptance and Commitment Therapy (ACT) is a promising intervention for cancer survivors, but its mechanisms in real-world settings are not fully understood. This study examined ACT-specific and broader target processes as mediators in the Valued Living randomized controlled trial, which compared ACT and usual care for anxious cancer survivors in a real-world community oncology setting.Method: Two ACT-specific target processes (experiential avoidance and values-aligned behavior, each measured with two validated instruments) and two broader target processes (emotional approach coping and self-compassion) were analyzed at Pre- and Post-intervention as predictors and mediators of anxiety symptoms, cancer-related trauma symptoms, and fear of cancer recurrence in a causal steps framework (n = 117). Results: During the intervention, ACT participants improved significantly more than usual care participants on the broader target processes (ps <= .035) but not the ACT-specific target processes (ps >= .080). Cancer-related emotional approach coping mediated cancer-related trauma symptoms and fear of recurrence (ps .043-.044). Self-compassion mediated fear of recurrence (p = .045), and showed marginal patterns for trauma symptoms (p = .059) and anxiety symptoms (p = .084).Conclusion: ACT may work in real-world settings for cancer survivors by promoting self-compassion and coping through emotional processing and expression.
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