HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT06930846
Status
Recruiting

Conditions

  • Brain Cancer
  • Brain Neoplasms
  • Brain Tumor
  • Cognitive Dysfunction
  • Low Grade Astrocytoma
  • Low-grade Glioma
  • Memory Disorders
  • Memory Dysfunction
  • Memory Impairment
  • Meningioma
  • Oligodendroglioma
  • Primary Brain Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HOBSCOTCH-CA — BEHAVIORAL
    HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-CA is an adaptation of the HOBSCOTCH program for people who are survivors of brain cancer or a brain tumor that incorporates education about the effects from brain cancer/tumor and its treatment on cognition into the education module and gives them the option of enrolling with a Caregiver. CA Participants receive all sessions of HOBSCOTCH-CA. If they enroll with a Caregiver, the Caregiver participates in the education (introductory) session and sessions 1 and 8. The HOBSCOTCH-CA Participant may invite their Caregiver to attend all sessions.

Study Details

The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-CA, to improve the quality of life and cognitive function in Service Members, Veterans and civilians who are survivors of brain cancer or a brain tumor (CA participants). This study will also assess the ability of the HOBSCOTCH-CA program to improve quality of life in caregivers of patients with brain cancer/tumor and to reduce caregiver burden. Enrolling with a Caregiver is optional for CA participants. Investigators will compare two groups of CA participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOCTCH-CA immediately (Group 1) and another group that will receive HOBSCOTCH-CA (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total. HOBSCOTCH-CA involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a "pre" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. CA participants are asked to do short homework assignments and keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).

Key Dates

Start date
Nov 3, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: CA Participant-Group 1
    After enrollment and completion of baseline assessments, CA Participant Group 1 will receive the HOBSCOTCH-PTE intervention consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions (option to do on webcam) * 1 wrap-up session (webcam or telephone)
  • Active Comparator: CA Participant-Group 2
    After a 3-month waiting period and having completed baseline and 3-month study assessments, CA Participant Group 2 will receive the HOBSCOTCH-CA intervention consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 6 telephone sessions (option to do on webcam) * 1 wrap-up session (webcam or telephone)
  • Experimental: CA Participant Caregiver-Group 1
    After enrollment and completion of baseline assessments, CA Participant Caregiver Group 1 will receive an adapted version of HOBSCOTCH-CA alongside the CA participant by attending: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 1 wrap-up session (webcam or telephone)
  • Active Comparator: CA Participant Caregiver-Group 2
    After a 3-month waiting period and having completed baseline and 3-month study assessments, CA Participant Caregiver Group 2 will receive an adapted version of HOBSCOTCH-CA alongside the CA participant by attending: * 1 pre-HOBSCOTCH Session (on webcam) * 1 educational session (on webcam) * 1 wrap-up session (webcam or telephone)

Primary Outcome Measure

Change in quality of life as measured by comparing Neuro-QOL scores at baseline and at 3 months post-intervention in CA Participants. [ Time Frame: Baseline and 3 months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Health LebanonLebanonNew Hampshire03756
Kathryn Giordano
603-650-4225
Sarah J. Kaden, BA
603-650-4225
Elaine T. Kiriakopoulos, MD, MPH, MSc (PRINCIPAL_INVESTIGATOR)

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