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

Trial Summary

What is the purpose of this trial?

The goal of this study is to test a psychosocial intervention called ASCENT (ACT-based Supportive intervention for patients with CENTral nervous system tumors). This intervention was developed to help patients after being diagnosed with a brain tumor. The main question this study aims to answer is whether this intervention is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in 6 coaching sessions and complete short surveys at four different time points. Some participants will be asked to share feedback via interviews.

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 data supports the effectiveness of the treatment ASCENT for brain cancer?

Research shows that behavioral pain interventions, like those used in ASCENT, can reduce pain and improve outcomes for cancer patients, especially in underserved areas. These interventions have been effective in reducing pain severity and improving physical and psychological well-being in similar contexts. ^{1 2 3 4 5}

Is the psychosocial intervention for brain cancer safe for humans?

The intervention has been tested in American Indian cancer patients and showed improvements in managing symptoms like pain, depression, and fatigue, suggesting it is safe and beneficial for symptom management. ^{6 7 8 9 10}

How is the psychosocial intervention for brain cancer different from other treatments?

This psychosocial intervention is unique because it focuses on improving the management of cancer-related symptoms like pain, depression, and fatigue through tailored education and behavioral strategies, rather than using medication. It may involve mobile-health technologies to reach underserved patients, making it accessible and feasible for those who might not have easy access to traditional healthcare services. ^{1 2 6 7 11}

Research Team

Deborah Forst, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Improving Functional Status in African Americans With Cancer Pain: A Randomized Clinical Trial [2022]

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

Is race/ethnicity related to the presence or severity of pain in colorectal and lung cancer? [2022]

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

A pilot study of relationships among pain characteristics, mood disturbances, and acculturation in a community sample of Chinese American patients with cancer. [2022]

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

Behavioral cancer pain intervention using videoconferencing and a mobile application for medically underserved patients: Rationale, design, and methods of a prospective multisite randomized controlled trial. [2022]

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

Cognitive Testing of PAIN Report It-Spanish in Monolingual Hispanic Adults. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cancer-Related Symptom Management Intervention for Southwest American Indians. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Hispanic breast cancer patients' symptom experience and patient-physician communication during chemotherapy. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Adaptation of a Multimedia Chemotherapy Educational Intervention for Latinos: Letting Patient Narratives Speak for Themselves. [2023]

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

Racial Differences in Pain Management for Patients Receiving Hospice Care. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

We Don't Talk about It: Cancer Pain and American Indian Survivors. [2020]

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

Development and pilot testing of an mHealth behavioral cancer pain protocol for medically underserved communities. [2023]