Supportive Psychoeducational Intervention for Patients With Brain Tumors (Acceptance and Commitment Therapy-based Supportive Intervention for Patients With Central Nervous System Tumors)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

The goal of this study is to refine and 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18

Massachusetts General Hospital Cancer Center Patient

Diagnosed with a malignant primary Central Nervous System (CNS) tumor

English speaking

Disqualifiers

Inability to provide informed consent as assessed by the study team (e.g., due to severe cognitive impairment/dementia)

Moderate to severe receptive aphasia (Quick Aphasia Battery sentence comprehension subscale < 8)

Deemed by treating team to have less than 6 month life expectancy, including patients with current or imminent hospice enrollment

Current participant in the NeuroTransitions (23-574) or NeuroPathways (23-178) studies at Massachusetts General Hospital

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychosocial intervention

    Behavioral

    Intervention manual and six one-on-one coaching sessions.

  • Usual supportive care

    Other intervention

    Referral to cancer center supportive care services (e.g., social work) as needed, upon request from the patient, caregiver, or clinician.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Pilot RCT: ASCENT ArmExperimental treatment 1 intervention
Group B: Pilot RCT: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of the Intervention: Percentage of Eligible Patients Who Enroll and Participate in the Intervention

The investigators will assess feasibility by examining the percentage of eligible patients who agree to enroll in the study and the percentage of enrolled patients who participate in all six intervention sessions. The intervention will be deemed feasible if at least 60% of eligible patients enroll in the study and if at least 70% of enrolled patients complete at least half of the sessions.

Time frame
Up to 12 weeks
2

Acceptability of the Intervention: Percentage of Participants who Have High Satisfaction with the Intervention

The investigators will assess acceptability via examining the distribution of patient scores for the 8-item Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8 to 32, with higher scores indicating higher satisfaction. The intervention will be deemed acceptable if at least 70% of patients score at least 24 points on the CSQ-8.

Time frame
12 weeks

Secondary outcomes

1

Exploratory: Coping Skills

The investigators will explore the effect of ASCENT on coping skills using the Measure of Current Status (MOCS) Part A. The MOCS Part A is a 13-item measure of self-perceived coping skills with scores ranging from 0-52 with higher scores indicating higher self-perceived coping skills.

Time frame
Up to 16 weeks
2

Exploratory: Values-driven behavior

The investigators will explore the effect of the ASCENT intervention on values driven behavior using the Valued Living Questionnaire (VLQ). In this questionnaire, respondents rate the importance of 10 domains of living and their consistency living in accordance with those values in the past week. Scores range from 10-100 with higher scores indicating a value with more importance.

Time frame
Up to 16 weeks
3

Exploratory: Prognostic distress

The investigators will explore the effect of the ASCENT intervention on prognostic awareness using the Prognostic Awareness Impact Scale (PAIS). This 34-item questionnaire measures three domains: cognitive understanding of prognosis, emotional coping with prognosis, and adaptive response (i.e., the capacity to use prognostic awareness to inform life decisions). The cognitive understanding domain consists of two items including a question asking patients if their oncologist has said that their cancer is curable and a question asking patients to report the likelihood that they would be cured of their cancer, assessed on a 7-point scale ranging from no chance/0% to extremely likely/\>90%. The emotional coping domain consists of eight items, with a score range of 0-24, with higher scores indicating better emotional coping with prognosis. The adaptive response domain consists of 12 items, with a score range of 0-36, with higher scores indicating better adaptive response to prognosis

Time frame
Up to 16 weeks
4

Exploratory: Depression symptoms

The investigators will explore the effect of the ASCENT intervention on depression symptoms using the Patient Health Questionnaire -8 (PHQ-8) The PHQ-8 is an 8 item measure with scores ranging from 0-24 and higher scores indicating more severe depression.

Time frame
Up to 16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Cancer Institute (NCI)

Collaborator