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

Overview

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).

Detailed description

The investigators' hypothesis is that the home-based intervention (HOBSCOTCH-CA) will improve quality of life and cognitive function in Service Members, Veterans and civilians with who are survivors of brain cancer or tumor. Also, that the integration of family caregiver participation in the HOBSCOTCH-CA intervention will reduce caregiver burden and increase caregiver knowledge of their loved one's disease and the cognitive challenges they face, ultimately leading to an improvement in caregiver quality of life (QOL).

The investigators will test the hypothesis by pursuing the following specific aims:

Aim 1: Adapt the HOBSCOTCH program education module for delivery to patients with brain cancer/tumor (CA participant) and cognitive challenges.

The investigators' working hypothesis is that the existing education module of the HOBSCOTCH program can be adapted to address key knowledge areas for patients with brain cancer/tumor and their caregivers.

Aim 2: Evaluate the efficacy of the HOBSCOTCH-CA program in patients with brain cancer/tumor.

The investigators' working hypothesis is that the HOBSCOTCH-CA intervention will improve quality of life (QOL) in CA participants. The investigators also expect to see improvements in subjective cognition, knowledge, self-efficacy, symptom reduction, and health outcomes.

Aim 3: Incorporate family caregivers into select components of the HOBSCOTCH-CA intervention and evaluate the effects of the HOBSCOTCH-CA intervention on the caregiver.

The investigator's working hypothesis is that family caregivers will have improvement in QOL and reduced caregiver burden and improved health status as a result of their family member with CA participating in the HOBSCOTCH-CA intervention, and by their own participation in the HOBSCOTCH-CA modules delivering disease specific education and mindfulness skill building exercises.

Interventions

• Behavioral HOBSCOTCH-CA
  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 ef

Primary outcome measures

• 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]
• Change in quality of life as measured by comparing FACT-Br scores at baseline and at 3 months post-intervention in CA Participants. [Time frame: Baseline and 3 months post-intervention]
• Change in subjective cognitive function as measured by comparing scores on the Cognitive Function Sub-Scale (Item Bank 2.0) of the Neuro-QOL at baseline and at 3 months post-intervention in CA Participants. [Time frame: Baseline and 3 months post-intervention]
• Change in CA Participant Caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention in Caregivers of CA Participants. [Time frame: Baseline and 3 months post-intervention]

Secondary outcome measures (12)

• Changes in CA Participant knowledge of relationship between their condition and cognition and memory as measured by comparing scores on the HOBSCOTCH-CA Knowledge Questionnaire at baseline and at 6 months (end of study) [Time frame: Baseline and at 6 months (at the end of the study).]
• Changes in CA Participants' objective cognition as measured by comparing scores on the Montreal Cognitive Assessment (MoCA) at baseline and at 3 months post-intervention. [Time frame: Baseline and 3 months post-intervention]
• Changes in CA Participants' subjective cognition as measured by comparing scores on the Everyday Memory Questionnaire (EMQ) at baseline and at 3 months post-intervention. [Time frame: Baseline and 3 months post-intervention]
• Changes in CA participants' executive function as measured by comparing scores on the self-reported Behavior Inventory of Executive Function-Adult Version (BRIEF-A) at baseline and 3-months post intervention. [Time frame: Baseline and 3 months post-intervention]
• Changes in CA participants' self-efficacy as measured by comparing scores on the PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v1.0 General Self-Efficacy assessment at baseline and 3-months post-intervention. [Time frame: Baseline and 3 months post-intervention]
• Changes in CA Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention. [Time frame: Baseline and 3 months post-intervention]
• Changes in CA participants' anxiety as measured by comparing score on the Generalized Anxiety Disorder-7 (GAD-7) at baseline and at 3-months post-intervention. [Time frame: Baseline and 3 months post-intervention]
• Changes in CA participants' symptom frequency as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention. [Time frame: Recorded daily and compared between baseline and 3 months post-intervention.]
• Changes in CA participants' medication adherence as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention. [Time frame: Recorded daily and compared between baseline and 3 months post-intervention.]
• Changes in CA participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention. [Time frame: Recorded daily and compared between baseline and 3 months post-intervention.]
• Changes in CA participants' self-reports of wellbeing as measured by comparing daily reports of well-being in a diary at baseline and at 3 months post-intervention. [Time frame: Recorded daily and compared between baseline and 3 months post-intervention.]
• Engagement and Satisfaction for CA Participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study. [Time frame: At 6 months (end of the study).]

Eligibility criteria

CA Participants will be referred to the study by their providers (Oncologist) who will be made aware of the study and inclusion/exclusion criteria. Inclusion Criteria 2. - 5. and Exclusion Criteria 1. - 3. will be confirmed by referring providers. Participants who learn about the study here and elsewhere will be instructed on how to confirm their eligibility with their provider.

Inclusion Criteria for CA Participant:

• 18 + years
• Service members, Veterans and civilians with a diagnosis of brain cancer (excluding glioblastoma)
• Diagnosis of primary brain tumor with expected survival of 2 years or greater (e.g., low-grade glioma, oligodendroglioma, IDH mutant astrocytoma, meningioma) defined as the presence of a primary lesion on neuroimaging (CT or MRI), confirmed by histopathological examination (Note: some patients being treated for meningioma may be treated with radiotherapy without need for initial histopathologic confirmation)
• Patients undergoing surgical and/or radiation therapy will have completed their treatment at least 3 months prior to being enrolled in trial (Note: patients receiving chemotherapy or other systemic therapy will be included)
• Stable on all CNS acting medications for one month prior to enrollment
• Subjective cognitive complaints
• Literate and proficient in English
• Internet access for the pre-session and Session 1 of the HOBSCOTCH-CA program; telephone access for sessions 2-8

Exclusion Criteria for CA Participant:

• Presence of a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
• Acute psychiatric disorder or substance abuse
• Patients with glioblastoma (GBM)

Inclusion Criteria for CA Participant Caregiver:

• Age 18 +
• Caregiver to a patient with a confirmed diagnosis of brain cancer/tumor survivor
• CA Subject has given permission for their caregiver to participate
• Literate and proficient in English
• Internet access (for Pre-HOBSCOTCH and Session 1)
• Telephone access (for Session 8)

Exclusion Criteria for CA Participant Caregiver:

• Significant visual impairment precluding reading or writing
• No reliable telephone or internet access

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Dartmouth-Health Lebanon — Lebanon

Identifiers

NCT: NCT06930846 · STUDY02002841

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗