Acceptance and Commitment Therapy for Cancer-Related Psychological Symptoms

(ACTION Trial)

Overseen By Miryam Yusufov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Opioids

Disqualifiers: Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories The names of the study intervention and research activities involved in this study are/is: * Acceptance \& Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist) * Questionnaires * Post-study interview Consistent with the NIH Stage Model for Behavioral Intervention Development, the investigators have adapted an existing, empirically-validated intervention, Acceptance and Commitment Therapy (ACT), to address substance use disorder risk during cancer care. The core components of ACT are particularly well-suited to address the psychological processes underlying opioid misuse in individuals treated for cancer pain. The overarching aim is to assess the feasibility and acceptability of the intervention by conducting a randomized pilot trial of the revised intervention ("ACTION") for cancer patients on opioid therapy, and at risk for SUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should currently be on opioid therapy, so you may need to continue with that specific medication.

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for cancer-related psychological symptoms?

Research shows that Acceptance and Commitment Therapy (ACT) can improve quality of life and help cancer patients manage psychological stress. Studies have found that ACT increases psychological flexibility, which helps patients adapt better to their condition. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for cancer patients?

Acceptance and Commitment Therapy (ACT) has been studied in cancer patients and is generally considered safe. It has shown improvements in quality of life and reductions in distress and emotional disturbances, with no significant safety concerns reported in the available studies. ^{2 5 6 7 8}

How is Acceptance and Commitment Therapy (ACT) different from other treatments for cancer-related psychological symptoms?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on increasing psychological flexibility, helping patients adapt better to their condition by accepting their thoughts and feelings rather than trying to change them. This approach is part of the third wave of cognitive behavioral therapy and is particularly promising for addressing the psychological distress associated with cancer. ^{1 4 5 8 9}

Research Team

Miryam Yusufov, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with any type of cancer, expected to live at least 6 more months, and who are on opioid therapy with a risk for substance use disorder. They should be able to do daily activities with little to no help and must understand English well enough for psychotherapy.

Inclusion Criteria

Score at least 4 on the Opioid Risk Tool (ORT)

Have an estimated survival time of at least 6 months (as estimated by palliative care provider)

I can take care of myself, though I may have some symptoms.

Exclusion Criteria

I am capable of participating in and completing study activities.

Not speak and comprehend English sufficiently to be able to participate in psychotherapy

I am currently taking opioid medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Acceptance & Commitment Therapy (ACT) for Cancer, involving 6 sessions with a licensed clinical psychologist

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a post-study interview

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• Acceptance & Commitment Therapy (ACT) for Cancer

Trial Overview The study tests Acceptance & Commitment Therapy (ACT) adapted for cancer patients at risk of substance misuse due to opioid pain treatment. It involves six sessions with a psychologist, questionnaires, and an interview after the study.

Participant Groups

Group I: INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE Experimental Treatment 1 Intervention

Participants will participate in a six-session behavioral intervention, delivered by a licensed clinical psychologist.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A pilot study involving 25 cancer patients tested an Acceptance and Commitment Therapy (ACT) group intervention, showing promising results in reducing fear of progression, depression, and psychological inflexibility, while improving psychological health-related quality of life and well-being.

The high adherence rate among participants suggests that the ACT-based intervention is feasible for use in outpatient settings, although further research with randomized controlled trials is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development and Evaluation of an Acceptance and Commitment Therapy (ACT)-Based Group Intervention for Cancer Patients with Psychological Burden]. Sauer, C., Maatouk, I.[2022]

Acceptance and Commitment Therapy (ACT) significantly improved emotional approach coping and self-compassion in 134 anxious cancer survivors, leading to reduced anxiety-related symptoms, particularly cancer-related trauma.

The study found that self-compassion and emotional approach coping were key mediators in ACT's effectiveness, suggesting that enhancing these qualities can help alleviate anxiety and fear of cancer recurrence in survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention and mediation effects of target processes in a randomized controlled trial of Acceptance and Commitment Therapy for anxious cancer survivors in community oncology clinics. Fishbein, JN., Judd, CM., Genung, S., et al.[2022]

Acceptance and Commitment Therapy (ACT) is a promising psychological intervention that helps terminally ill cancer patients manage physical, psychological, and social challenges, ultimately enhancing their quality of life.

There is strong evidence from international studies supporting the effectiveness of ACT in improving health-related outcomes for patients, caregivers, and healthcare professionals, highlighting the need for further research in South Korea's hospice and palliative care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Acceptance and Commitment Therapy (ACT) in Hospice and Palliative Care Settings. Park, SY.[2023]

Acceptance and Commitment Therapy (ACT) significantly increases hope in women with cancer, as shown by a study involving 24 participants who underwent pre-test and post-test assessments.

The research indicates that ACT can enhance psychological flexibility and adaptability in cancer patients, suggesting it may be a beneficial therapeutic approach during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Acceptance and Commitment Therapy on Life Expectancy of Female Cancer Patients at Tehran's Dehshpour Institute in 2015. Ghasemi, F., Dehghan, F., Farnia, V., et al.[2017]

A study involving 203 post-treatment cancer survivors identified three symptom severity classes, revealing that those with higher symptom burdens (like fatigue and anxiety) showed lower levels of mindfulness and acceptance.

The results support the Acceptance and Commitment Therapy (ACT) model, suggesting that survivors with greater symptom distress are less engaged in meaningful activities and less accepting of their experiences, highlighting the need for further research on ACT's effectiveness in alleviating suffering in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. Lewson, AB., Johns, SA., Krueger, E., et al.[2022]

Acceptance and Commitment Therapy (ACT) may provide a more effective approach for cancer patients by addressing their unique psychological and coping needs, as current psychological interventions often focus too narrowly on psychopathological outcomes.

Preliminary studies suggest that ACT could be clinically and cost-effective for cancer patients, including those with psychological comorbidities, indicating its potential as a valuable addition to existing cancer care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. Hulbert-Williams, NJ., Storey, L., Wilson, KG.[2022]

Acceptance and Commitment Therapy (ACT) has shown promise in improving quality of life and psychological flexibility while reducing emotional distress and physical pain in cancer patients, based on a review of six studies including randomized controlled trials and cohort studies.

Despite the limited number of studies, the evidence suggests that ACT can be an effective psychotherapeutic approach for individuals facing various types of cancer, highlighting the need for further research across different cancer populations and stages of illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Acceptance and Commitment Therapy in Oncology Settings: A Narrative Review. Fashler, SR., Weinrib, AZ., Azam, MA., et al.[2022]

Acceptance and Commitment Therapy (ACT) has been shown to significantly reduce anxiety, depression, and fear of cancer recurrence in a systematic review of 13 studies involving 537 cancer survivors.

The review suggests that ACT can improve psychological flexibility and quality of life for cancer survivors, but highlights the need for more rigorous studies to explore its effects on other symptoms like pain and insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy in adult cancer survivors: a systematic review and conceptual model. Mathew, A., Doorenbos, AZ., Jang, MK., et al.[2023]

Acceptance and Commitment Therapy (ACT) significantly improved mental health outcomes in cancer patients, reducing depression and anxiety, and enhancing quality of life, based on a review of 17 randomized controlled trials involving 877 participants.

Despite the overall low quality of the studies, ACT showed lasting benefits for mental health, with significant improvements observed even 6 months after treatment, indicating its potential as a valuable part of cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of acceptance and commitment therapy for mental illness in cancer patients: A systematic review and meta-analysis of randomised controlled trials. Li, Z., Li, Y., Guo, L., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Development and Evaluation of an Acceptance and Commitment Therapy (ACT)-Based Group Intervention for Cancer Patients with Psychological Burden]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Intervention and mediation effects of target processes in a randomized controlled trial of Acceptance and Commitment Therapy for anxious cancer survivors in community oncology clinics. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Application of Acceptance and Commitment Therapy (ACT) in Hospice and Palliative Care Settings. [2023]

4. Thailand pubmed.ncbi.nlm.nih.gov

Effectiveness of Acceptance and Commitment Therapy on Life Expectancy of Female Cancer Patients at Tehran's Dehshpour Institute in 2015. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Psychological interventions for patients with cancer: psychological flexibility and the potential utility of Acceptance and Commitment Therapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Use of Acceptance and Commitment Therapy in Oncology Settings: A Narrative Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy in adult cancer survivors: a systematic review and conceptual model. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Effectiveness of acceptance and commitment therapy for mental illness in cancer patients: A systematic review and meta-analysis of randomised controlled trials. [2021]