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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Acceptance and Commitment Therapy (ACT) to help cancer patients manage psychological symptoms and reduce the risk of opioid misuse. Participants attend six sessions with a psychologist to learn new strategies for handling difficult thoughts and feelings. This trial suits those with cancer who are on opioid therapy and concerned about substance use issues. As an unphased trial, it offers participants the chance to explore innovative therapy techniques that could enhance their quality of life.

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 prior data suggests that Acceptance & Commitment Therapy (ACT) for Cancer is safe?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally safe for people with cancer. Studies have found that it can improve quality of life and help manage emotional challenges like anxiety and fear. Since ACT does not involve medication, it has fewer physical side effects than drug treatments. This therapy helps individuals accept their thoughts and feelings while encouraging actions that align with their values. Overall, patients have responded well to ACT, making it a promising option for managing emotional symptoms in cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for cancer-related psychological symptoms because it offers a fresh approach to managing distress often associated with cancer. While standard treatments for psychological symptoms in cancer patients, such as medications and traditional talk therapy, focus on symptom reduction, ACT emphasizes acceptance of difficult emotions and commitment to personal values. This method can empower patients to live meaningful lives despite their cancer-related challenges. By shifting the focus from controlling negative thoughts to embracing them, ACT could provide a more flexible and enduring way for patients to cope with their symptoms.

What evidence suggests that Acceptance & Commitment Therapy (ACT) is effective for cancer-related psychological symptoms?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial will receive, helps reduce stress, depression, and anxiety in cancer patients. Studies have found that it also improves quality of life and assists with emotional challenges. ACT specifically helps manage the fear of cancer returning and reduces the tendency to avoid problems. It has proven effective in easing symptoms of depression and overall stress. This makes ACT a promising approach to support emotional well-being for those undergoing cancer treatment. ^{3 6 7 8 9}

Who Is on the Research Team?

Miryam Yusufov, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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) 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) 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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10796538/

a systematic review and meta-analysis of randomized ... These studies summarized the efficacy of ACT on psychological distress or other symptoms (fatigue and sleep disturbance) in people with cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2212144724000905

The effects of acceptance and commitment therapy (ACT ... Overall results indicate that ACT interventions reduce psychological distress, depression and anxiety, and increase HRQoL. Efficacy relating to other outcome ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12175782/

Application of acceptance and commitment therapy in cancer ... The trial designs varied, but ACT has shown significant effects in improving emotional disorders, adaptive functioning, and quality of life in cancer patients, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748921000080

Effects of Acceptance and Commitment Therapy on health ... Two out of the five studies reported Acceptance and Commitment Therapy significantly reduced depressive symptoms and psychological distress post-intervention ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06823-2

The effectiveness of internet-based acceptance and ... ACT is helpful in dealing with the fear of cancer coming back and it also leads to big improvements in avoiding problems, anxiety, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560379/

The effect of acceptance commitment therapy on the mental ... ACT has demonstrated its efficacy for cancer patients by teaching adaptive management of disease-related pain, including uncertainty, anxiety, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1462388925000869

Acceptance and commitment therapy effectiveness for fear ... ACT can effectively reduce FCR, experiential avoidance, and anxiety in cancer survivors, though it did not significantly affect fatigue levels.

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1253266/full

a systematic review and meta-analysis of randomized ... The results revealed that ACT significantly reduced psychological distress levels and improved psychological flexibility in postintervention ...

9. withpower.com withpower.com/trial/phase-psychological-1-2023-c4fd8

Acceptance and Commitment Therapy for Cancer-Related ... 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 ...