Dartmouth-Health Lebanon
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
Location contact
Elaine T. Kiriakopoulos, MD, MPH, MSc
PRINCIPAL_INVESTIGATOR
Kathryn Giordano
CONTACT
Sarah J. Kaden, BA
CONTACT
NCT Number: NCT06930846
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Lebanon, New Hampshire, 03756, United States
Location status: Recruiting
Elaine T. Kiriakopoulos, MD, MPH, MSc
PRINCIPAL_INVESTIGATOR
Kathryn Giordano
CONTACT
Sarah J. Kaden, BA
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Exclusion criteria
for CA Participant:
Inclusion criteria
for CA Participant Caregiver:
Exclusion criteria
for CA Participant Caregiver:
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.
Other names: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)
Time frame: Baseline and 3 months post-intervention
The Neuro-QOL is a self-reported, validated assessment on health-related quality of life covering 17 domains in individuals with neurological disorders. Items are scored on a 5-point Likert scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. Depending on the domain, a higher or lower score can indicate better or poorer quality of life for that domain.
Time frame: Baseline and 3 months post-intervention
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a validated instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales or domains. A 5-point Likert scale from 0 (not at all) to 4 (very much) is utilized with a higher score representing poorer or better QOL depending on the domain.
Time frame: Baseline and 3 months post-intervention
The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Time frame: Baseline and 3 months post-intervention
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.
Time frame: Baseline and at 6 months (at the end of the study).
Time frame: Baseline and 3 months post-intervention
The Montreal Cognitive Assessment (MOCA) is a validated 30 item test that helps healthcare professionals detect cognitive impairments. The test examines seven domains (aspects) of cognitive function with a total of 11 different exercises and tasks including: executive and visuospatial function, naming, attention, language, abstraction, delayed recall, orientation. Scores range from 0 - 30 with higher scores indicating less cognitive impairment.
Time frame: Baseline and 3 months post-intervention
The Everyday Memory Questionnaire (EMQ) is a validated assessment that was developed as a subjective measure of memory failure in everyday life. It is composed of 13 items, with a Likert-type scale ranging from "once or less in the last month" (1) to "once or more once per day" (5); higher values indicate the presence of subjective memory complaints.
Time frame: Baseline and 3 months post-intervention
The BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment that includes 75 items within nine scales of executive function. All 75 items are rated in terms of frequency on a 3-point scale: 0 (never), 1 (sometimes), 2 (often). Raw scores for each scale are summed and T scores (M = 50, SD = 10) are used to interpret the individual's level of executive functioning. Higher scores indicate greater impairment in executive functioning.
Time frame: Baseline and 3 months post-intervention
The PROMIS self-efficacy scales is a validated measure designed to assess an individual's confidence in managing various situations, problems and events. 10 items are self-reported on a scale of 1 (I am not at all confident) to 5 (I am very confident). Lower scores indicate poorer perception of self-efficacy.
Time frame: Baseline and 3 months post-intervention
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria on a 4-point Likert scale as "0" (not at all) to "3" (nearly every day). Higher scores are consistent with greater symptoms of poor mood or depression.
Time frame: Baseline and 3 months post-intervention
The Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for measuring symptoms of generalized anxiety disorder (GAD). The seven items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores suggest greater symptoms of anxiety.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention.
CA participants will self-report symptoms related to their brain cancer/tumor using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention.
CA participants will self-report their medication adherence activity using a smartphone app or paper log. The smart phone app was developed by the HOBSCOTH program at Dartmouth-Hitchcock and is used clinically in the HOBSCOTCH program.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention.
CA participants will self-report their use of the memory strategies they learn in the HOBSCOTCH-CA program using a smartphone app developed by the HOBSCOTH program at Dartmouth-Hitchcock or in a paper log.
Time frame: Recorded daily and compared between baseline and 3 months post-intervention.
The researchers will collect daily well-being information throughout the entire study by use of a smartphone app or paper log and a basic single item Likert-scale of well-being.
Time frame: At 6 months (end of the study).
The Participant Satisfaction Survey has been developed through the original HOBSCOTH program and is used in clinical practice for quality improvement. It contains 10 items scored on a 5-point Likert scale with a higher score indicating greater satisfaction with the program. Participants also have the option to write open text about their experiences in the HOBSCOTCH-CA intervention.
Time frame: At 6 months (end of the study).
CollaboRATE is a brief, 3 item patient-reported measure of shared decision making, namely the perception of being informed and then involved in decision-making steps. A 10-point anchor scale from 0 (no effort was made) to 9 (every effort was made) with higher scores representing a greater perception of a shared decision-making effort.
Time frame: At the beginning of HOBSCOTCH-CA (week 1) and at the end of the intervention (week 8).
Homework assignments are given each week in which participants are asked to think about solutions using the Problem-Solving Therapy taught in the program. Compliance is measured by Yes (completed homework assignment) or No (did not complete homework assignment).
Time frame: Baseline and 3 months post-intervention
The Short Form Health Survey (SF-36) is a validated 36-item, patient- reported survey of patient health. It consists of 8 sub-scales, which are scored on a 3-point, 5-point or dichotomous (yes/no or true/false) scale. The scores are converted to a 1 - 100-point scale with a lower score indicating more disability, i.e. 0 = maximum disability and 100 = no disability.
Time frame: Baseline and 3 months post-intervention
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria on a 4-point Likert scale as "0" (not at all) to "3" (nearly every day). Higher scores are consistent with greater symptoms of poor mood or depression.
Time frame: Baseline and 3 months post-intervention
The Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for measuring symptoms of generalized anxiety disorder (GAD). The seven items are scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). Higher scores suggest greater symptoms of anxiety.
Time frame: Baseline and at 6 months (end of study).
Time frame: At 6 months (end of study).
The Participant Satisfaction Survey was developed through the original HOBSCOTH program and is used in clinical practice for quality improvement. It has been modified to address Caregiver's satisfaction as a result or participating in this study and contains 9 items scored on a 5- point Likert scale with a higher score indicating greater satisfaction with the program.
Time frame: At 3 months and 6 months post-intervention
The Neuro-QOL is a self-reported, validated assessment on health-related quality of life covering 17 domains in individuals with neurological disorders. Items are scored on a 5-point Likert scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. Depending on the domain, a higher or lower score can indicate better or poorer quality of life for that domain.
Time frame: At 3 months and 6 months post-intervention
The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Time frame: At 3 months and 6 months post-intervention
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a validated instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales or domains. A 5-point Likert scale from 0 (not at all) to 4 (very much) is utilized with a higher score representing poorer or better QOL depending on the domain.
Time frame: At 3 months and 6 months post-intervention
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.
Contact information is provided by the study sponsor or research team.
Sarah J. Kaden, BA
CONTACT
Trina K Dawson, BA
CONTACT
Dartmouth-Hitchcock Medical Center
Other
Acronym: HOBSCOTCH-CA
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