Anxiety and Depression in Metastatic Cancer: A Critical Review of Negative Impacts on Advance Care Planning and End-of-Life Decision Making With Practical Recommendations.

PURPOSE: Providers treating adults with advanced cancer increasingly seek to engage patients and surrogates in advance care planning (ACP) and end-of-life (EOL) decision making; however, anxiety and depression may interfere with engagement. The intersection of these two key phenomena is examined among patients with metastatic cancer and their surrogates: the need to prepare for and engage in ACP and EOL decision making and the high prevalence of anxiety and depression. METHODS: Using a critical review framework, we examine the specific ways that anxiety and depression are likely to affect both ACP and EOL decision making. RESULTS: The review indicates that depression is associated with reduced compliance with treatment recommendations, and high anxiety may result in avoidance of difficult discussions involved in ACP and EOL decision making. Depression and anxiety are associated with increased decisional regret in the context of cancer treatment decision making, as well as a preference for passive (not active) decision making in an intensive care unit setting. Anxiety about death in patients with advanced cancer is associated with lower rates of completion of an advance directive or discussion of EOL wishes with the oncologist. Patients with advanced cancer and elevated anxiety report higher discordance between wanted versus received life-sustaining treatments, less trust in their physicians, and less comprehension of the information communicated by their physicians. CONCLUSION: Anxiety and depression are commonly elevated among adults with advanced cancer and health care surrogates, and can result in less engagement and satisfaction with ACP, cancer treatment, and EOL decisions. We offer practical strategies and sample scripts for oncology care providers to use to reduce the effects of anxiety and depression in these contexts.

A randomized controlled trial of a multi-modal palliative care intervention to promote advance care planning and psychological well-being among adults with advanced cancer: study protocol.

BACKGROUND: Up to half of adults with advanced cancer report anxiety or depression symptoms, which can cause avoidance of future planning. We present a study protocol for an innovative, remotely-delivered, acceptance-based, multi-modal palliative care intervention that addresses advance care planning (ACP) and unmet psychological needs commonly experienced by adults with metastatic cancer. METHODS: A two-armed, prospective randomized controlled trial (RCT) randomizes 240 adults with Stage IV (and select Stage III) solid tumor cancer who report moderate to high anxiety or depression symptoms to either the multi-modal intervention or usual care. The intervention comprises five weekly two-hour group sessions (plus a booster session one month later) delivered via video conferencing, with online self-paced modules and check-ins completed between the group sessions. Intervention content is based on Acceptance and Commitment Therapy (ACT), an acceptance, mindfulness, and values-based model. Participants are recruited from a network of community cancer care clinics, with group sessions led by the network's oncology clinical social workers. Participants are assessed at baseline, mid-intervention, post-intervention, and 2-month follow-up. The primary outcome is ACP completion; secondary outcomes include anxiety and depression symptoms, fear of dying, and sense of life meaning. Relationships between anxiety/depression symptoms and ACP will be evaluated cross-sectionally and longitudinally and theory-based putative mediators will be examined. DISCUSSION: Among adults with advanced cancer in community oncology settings, this RCT will provide evidence regarding the efficacy of the group ACT intervention on ACP and psychosocial outcomes as well as examine the relationship between ACP and anxiety/ depression symptoms. This trial aims to advance palliative care science and inform clinical practice. TRIAL REGISTRATION: Clinicaltrials.gov NCT04773639 on February 26, 2021.

Randomized Controlled Pilot Trial of a Low-Touch Remotely-Delivered Values Intervention to Promote Adherence to Adjuvant Endocrine Therapy Among Breast Cancer Survivors.

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.

Randomized trial of acceptance and commitment therapy for anxious cancer survivors in community clinics: Outcomes and moderators.

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 (ps ≤ .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. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Acceptability, Feasibility, and Efficacy Potential of a Multimodal Acceptance and Commitment Therapy Intervention to Address Psychosocial and Advance Care Planning Needs among Anxious and Depressed Adults with Metastatic Cancer.

Background: Adults with metastatic cancer frequently report anxiety and depression symptoms, which may impact health behaviors such as advance care planning (ACP). Objective: The study leveraged acceptance and commitment therapy (ACT), an evidence-based approach for reducing distress and improving health behaviors, and adapted it into a multimodal intervention (M-ACT) designed to address the psychosocial and ACP needs of anxious and depressed adults with metastatic cancer. The study evaluated M-ACT's acceptability, feasibility, and efficacy potential. Design: The study was designed as a single-arm intervention development and pilot trial. Setting/Subjects: The trial enrolled 35 anxious or depressed adults with stage IV cancer in community oncology clinics, with a referred-to-enrolled rate of 69% and eligible-to-enrolled rate of 95%. Measurements: M-ACT alternated four in-person group sessions with three self-paced online sessions. Acceptability and feasibility were assessed through enrollment, attendance, and satisfaction ratings. Outcomes and theorized intervention mechanisms were evaluated at baseline, midintervention, postintervention, and two-month follow-up. Results: Participant feedback was used to refine the intervention. Of participants starting the intervention, 92% completed, reporting high satisfaction. One-quarter did not begin M-ACT due to health declines, moving, or death. Completers showed significant reductions in anxiety, depression, and fear of dying and increases in ACP and sense of life meaning. In this pilot, M-ACT showed no significant impact on pain interference. Increases in two of three mechanism measures predicted improvement on 80% of significant outcomes. Conclusions: The M-ACT intervention is feasible, acceptable, and shows potential for efficacy in community oncology settings; a randomized trial is warranted.

A randomized controlled trial of a group acceptance-based intervention for cancer survivors experiencing anxiety at re-entry ('Valued Living'): study protocol.

BACKGROUND: Anxiety 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/DESIGN: This 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. DISCUSSION: This clinical trial will provide valuable evidence regarding the efficacy of the group ACT intervention in community oncology settings. TRIAL REGISTRATION: Clinicaltrials.gov NCT02550925 .