Psychosocial Intervention for Brain Cancer

Overseen By Deborah A Forst, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Severe cognitive impairment, Receptive aphasia, Hospice enrollment

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

Compensation: Varies

Number of Visits: 12

Duration: 6-12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support program called ASCENT (Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT) for individuals recently diagnosed with brain tumors. The goal is to determine if the program is helpful and feasible for patients. Participants will attend six coaching sessions and complete surveys at various times, with some also providing feedback in interviews. This trial suits patients at Massachusetts General Hospital diagnosed with a brain tumor in the past six months.

As an unphased trial, this study offers patients the chance to contribute to innovative support strategies that could improve care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this psychosocial intervention is safe for brain cancer patients?

Research has shown that the ASCENT program, which stands for ACT-based Supportive intervention for patients with CENTral nervous system tumors, is being tested in various settings to evaluate its effectiveness in helping cancer patients. Studies have found that similar programs for managing cancer pain are being explored, particularly among groups like rural and Hispanic cancer survivors.

While specific safety information for ASCENT in brain cancer patients is not available, these support programs are generally considered safe. They focus on providing emotional and psychological support rather than using drugs or medical procedures. As a result, they are usually well-tolerated, with few, if any, negative effects reported. Participants typically engage in coaching sessions that help them manage their condition, which many find helpful and non-threatening.

Overall, support programs like ASCENT aim to help patients manage their conditions and improve their quality of life, and they are usually safe and easy for patients to join. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ASCENT because it offers a new psychosocial approach for brain cancer patients that complements traditional medical treatments. Unlike standard care, which primarily focuses on physical health through surgery, chemotherapy, or radiation, ASCENT provides structured emotional and psychological support through individual sessions with a clinician. This intervention aims to improve patients' mental well-being, potentially enhancing overall treatment outcomes and quality of life. By integrating psychological care into the cancer treatment process, ASCENT could lead to more comprehensive care for brain cancer patients.

What evidence suggests that the ASCENT intervention is effective for brain cancer patients?

Research has shown that the ASCENT program, a support method based on Acceptance and Commitment Therapy (ACT), helps manage cancer-related pain, particularly in underserved communities. This program aims to enhance patients' emotional and mental well-being, positively impacting their overall health. In this trial, participants in the ASCENT arm will receive this intervention. Past studies have demonstrated that similar programs help patients manage cancer more effectively by reducing stress and improving quality of life. Although limited data exists specifically for brain cancer, these findings suggest that ASCENT could provide valuable support for those facing the emotional challenges of a brain tumor diagnosis. ^{1 2 3 5 6}

Who Is on the Research Team?

Deborah Forst, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were diagnosed with a malignant brain tumor within the last 6 months, are patients at Massachusetts General Hospital Cancer Center, and speak English. It's not for those unable to consent (due to severe cognitive issues), in or near hospice care, or with significant difficulty understanding language.

Inclusion Criteria

Massachusetts General Hospital Cancer Center Patient

English speaking

I was diagnosed with a brain tumor less than 6 months ago.

Exclusion Criteria

You have significant difficulty understanding and processing spoken language.

I am able to understand and consent to participate in the study.

You are currently in or about to join a hospice program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ASCENT intervention, consisting of six weekly or biweekly individual sessions with a clinician

6-12 weeks

6 sessions (in-person or virtual)

Follow-up

Participants are monitored for psychological and behavioral outcomes, including depression, loneliness, anxiety, coping skills, prognostic distress, and quality of life

16 weeks

Surveys at baseline, 6 weeks, 12 weeks, and 16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ASCENT

Trial Overview The study tests ASCENT, a psychosocial intervention designed to support brain tumor patients emotionally and mentally. Participants will undergo six coaching sessions and complete surveys at four times during the study. Some will also provide feedback through interviews.

How Is the Trial Designed?

Group I: Pilot RCT: ASCENT Arm Experimental Treatment 1 Intervention

Enrolled patients will receive an intervention manual and will participate in six weekly or biweekly individual sessions with a clinician (e.g. nurse or behavioral health specialist). Participants will be asked to complete surveys at baseline, 6 weeks, 12 weeks, and 16 weeks.

Group II: Pilot RCT: Control Arm Active Control 1 Intervention

Participants will receive usual supportive care, which includes referral to cancer center supportive care services (e.g., social work) upon request from the patient, caregiver, or clinician. Participants will be asked to complete surveys at baseline, 6 weeks, 12 weeks, and 16 weeks.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

The Power Over Pain-Coaching (POP-C) intervention significantly improved functional status and reduced pain-related distress among 310 African American cancer patients, indicating its efficacy in managing cancer pain.

Participants in the POP-C group experienced a notable decrease in pain intensity ratings, particularly in the 'living with pain' aspect, highlighting the intervention's potential to enhance perceived control over pain and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Functional Status in African Americans With Cancer Pain: A Randomized Clinical Trial Hazard Vallerand, A., Hasenau, SM., Robinson-Lane, SG., et al.[2022]

American Indian cancer survivors often do not communicate about their pain and cancer experiences, which can lead to a lack of social support and reduced treatment compliance.

The study identified key barriers to communication, including cultural norms around discussing pain and death, and a strong respect for healthcare providers, highlighting the need for targeted educational interventions to improve symptom management and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We Don't Talk about It: Cancer Pain and American Indian Survivors. Hodge, FS., Itty, TL., Samuel-Nakamura, C., et al.[2020]

In a study of 64 older adults with cancer pain in hospice care, there were minimal differences in the implementation of pain management strategies between African American and Caucasian American patients, indicating overall comparable care.

However, African American patients had significantly lower assessments of primary pain characteristics and management of opioid-induced constipation, suggesting areas for improvement in pain management practices for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial Differences in Pain Management for Patients Receiving Hospice Care. Booker, SQ., Herr, KA., Wilson Garvan, C.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/xojS5z-Fg0aCHBuVOfZ0pw/project-details/10539159

Project Details - NIH RePORTER We plan to evaluate the effectiveness of this approach in a clinical trial entitled “Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer ...

2. mayoclinic.elsevierpure.com mayoclinic.elsevierpure.com/en/projects/achieving-equity-through-socioculturally-informed-digitally-enabl-7

Achieving Equity through SocioCulturally-informed, ... In addition, we have leveraged electronic health records (EHRs) to en- able care teams to link symptomatic cancer patients with MMPC providers and resources.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06198010

A Collaborative Intervention for Improving Cancer Pain ... This clinical trial tests a collaborative pain management intervention (ASCENT) for improving cancer pain in rural and Hispanic cancer survivors.

4. reporter.nih.gov reporter.nih.gov/search/haghzi7k-EWxFGs75kV4hA/project-details/11187218

Project Details The proposed Advancing Safe, Comprehensive, Digitally-Enabled Cancer Pain managemeNT (ASCENT) clinical trial will test whether a novel digitally enabled, ...

5. mayoclinic.elsevierpure.com mayoclinic.elsevierpure.com/en/projects/achieving-equity-through-socioculturally-informed-digitally-enabl-7/fingerprints/?sortBy=alphabetically

Achieving Equity through SocioCulturally-informed, ... Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT” (ASCENT) Clinical Trial ... Pain Outcomes 16%. Pain Treatment ...

6. prevention.cancer.gov prevention.cancer.gov/research-areas/networks-consortia-programs/scsm/grants?field_end_date_value=1&topic=85&field_major_program_target_id=28&viewsreference%5Bdata%5D%5Blimit%5D=&viewsreference%5Bdata%5D%5Bpager%5D=&viewsreference%5Bdata%5D%5Bargument%5D=Supportive%20Care%20and%20Symptom%20Management&viewsreference%5Bdata%5D%5Boffset%5D=&viewsreference%5Bdata%5D%5Btitle%5D=0&viewsreference%5Benabled_settings%5D%5Bargument%5D=argument&viewsreference%5Benabled_settings%5D%5Btitle%5D=title&viewsreference%5Bparent_entity_type%5D=paragraph&viewsreference%5Bparent_entity_id%5D=2458&viewsreference%5Bparent_field_name%5D=field_view&viewsreference%5Bcompressed%5D=eJxdjsEKwjAMhl-l5LyDiILs6tnTHqBEmtVA25Uum5Sxd7d14sRDyJ98-ZMsYFAQ2gUcexZoARqIaCltEpOdPIUKuinGIQnPpK6YSGEwqss-yuDVDUPxvAcbGPp-pM8qYXFU5AHWBijg3ZHRhQoHO9azPwe-crdtea0vpUJ0CZasJcdKSxNtwviA_wE2BR9P58tOeiZndEBfnVsxMz1hfQFRUVkA&order=field_pi_last_name&sort=asc&page=1

Grants | Division of Cancer Prevention Mayo Clinic Rochester United States. Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT” (ASCENT) Clinical Trial ...