Supportive Care Intervention for Brain Cancer

Recruiting in Boston (>99 mi)

Overseen By Deborah A Forst, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Severe cognitive impairment, Receptive aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This goal of this study is to test an information and support intervention for patients with malignant (or "high-grade") brain tumors. This study was developed to help patients cope after a brain tumor diagnosis. The main question this study aims to answer is whether this intervention (which includes access to an information guide and one-on-one coaching sessions) is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in the coaching sessions, use the guide as desired, and complete a small group of short surveys at three different points in time; some participants will be asked to share feedback via exit 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. It seems focused on providing support and information, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment Information and Support Intervention, NeuroPathways Intervention, Information and Support Intervention for Brain Tumor Patients?

Research shows that providing tailored information and support can help brain cancer patients and their caregivers feel more informed and supported, which can improve their overall experience and satisfaction with care. Similar approaches have been effective in meeting the supportive care needs of patients with other types of cancer, like breast cancer, by providing education and psychological support. ^{1 2 3 4 5}

Is the Supportive Care Intervention for Brain Cancer safe for humans?

The available research does not provide specific safety data for the Supportive Care Intervention for Brain Cancer or its related interventions. However, the studies suggest that participants generally found the interventions helpful and were satisfied with them, indicating no major safety concerns were reported. ^{1 6 7 8 9}

How is the I-CoPE supportive care treatment for brain cancer different from other treatments?

The I-CoPE treatment is unique because it focuses on structured supportive care for people with high-grade glioma and their family carers, involving staged information, regular needs screening, communication, and family engagement, rather than direct medical intervention. ^{3 10 11 12 13}

Research Team

Deborah Forst, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 who are patients at Massachusetts General Hospital Cancer Center, recently diagnosed (within 6 weeks) with a primary malignant brain tumor and can speak and read English. It's not suitable for those unable to consent due to severe cognitive issues or if their oncologist thinks it's inappropriate.

Inclusion Criteria

I was diagnosed with a brain tumor less than 6 weeks ago.

Massachusetts General Hospital Cancer Center patient

Able to speak and read in English

Exclusion Criteria

Deemed inappropriate to approach by patient's oncologist or study PI

I am able to understand and consent to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive an intervention guide and participate in four weekly or biweekly individual sessions with a clinician.

8 weeks

4 sessions (in-person or virtual)

Follow-up

Participants are monitored for psychological, behavioral, and cognitive outcomes, and complete surveys at baseline, 8 weeks, and 12 weeks.

4 weeks

3 survey points

Open-label extension (optional)

Participants may continue to receive supportive care and participate in exit interviews.

Long-term

Treatment Details

Interventions

• Information and Support Intervention

Trial Overview The study tests an information and support intervention designed to help brain tumor patients cope. It includes access to an info guide and one-on-one coaching sessions, assessing feasibility and acceptability through surveys and exit interviews.

Participant Groups

Group I: NeuroPathways Pilot RCT Experimental Treatment 1 Intervention

Enrolled patients will receive an intervention guide with information about navigating life with a brain tumor diagnosis, and will participate in four weekly or biweekly, individual sessions with a clinician (e.g. nurse or behavioral health specialist). Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks.

Group II: NeuroPathways Open Pilot Experimental Treatment 1 Intervention

Enrolled patients will receive an intervention guide with information about navigating life with a brain tumor diagnosis, and will participate in four weekly or biweekly, individual sessions with a clinician (e.g. nurse or behavioral health specialist). Participants will be asked to complete surveys at baseline, 8 weeks and 12 weeks, as well as an exit interview after the intervention.

Group III: Usual supportive care 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, 8 weeks and 12 weeks.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

A systematic review of 12 studies on adults with malignant cerebral glioma revealed that patient awareness of their prognosis varied, with relatives generally being more informed.

Patients and their families highly valued individualized communication and specialist nurse support, indicating a need for tailored information and care strategies, although no specific studies on effective communication interventions for this group were found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication, information and support for adults with malignant cerebral glioma : a systematic literature review. Davies, E., Higginson, IJ.[2022]

A study involving 80 Taiwanese women newly diagnosed with breast cancer showed that education and psychological support significantly reduced symptom distress and unmet supportive care needs at 1 and 3 months post-surgery compared to routine care.

Participants receiving the intervention also experienced significantly lower levels of state anxiety at both 1 and 3 months after surgery, highlighting the importance of ongoing psychological support for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and psychological support meet the supportive care needs of Taiwanese women three months after surgery for newly diagnosed breast cancer: a non-randomised quasi-experimental study. Liao, MN., Chen, SC., Lin, YC., et al.[2018]

Out of 113 studies on psychosocial care for brain cancer, most focused on a single component of care, with 77% of patient-reported and 71% of support person-reported studies assessing only one aspect.

Only 24% of studies included both patient and support person perspectives, highlighting a need for more comprehensive research that evaluates multiple components of care to improve psychosocial outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain cancer patient and support persons' experiences of psychosocial care: a mapping of research outputs. Boyd, LAP., Waller, AE., Hill, D., et al.[2021]

A study involving 109 patients and 77 caregivers revealed that both groups prioritized medical and physical information regarding brain metastases, focusing on symptoms, treatment options, and end-of-life support.

Patients preferred pamphlets for social, emotional, and spiritual information, while caregivers favored one-on-one counseling, highlighting the need for tailored informational resources to meet the specific needs of both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informational needs of brain metastases patients and their caregivers. Papadakos, J., Agarwal, A., Charow, R., et al.[2022]

Educational interventions for adults with primary brain tumors and their caregivers generally resulted in high satisfaction rates, with 9 out of 12 studies reporting positive feedback.

While some studies showed improvements in knowledge and information provision, the overall evidence is limited due to the small number of randomized controlled trials and potential biases in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of interventions to improve the provision of information for adults with primary brain tumors and their caregivers. Langbecker, D., Janda, M.[2022]

A new support intervention for caregivers of brain tumor patients was developed, utilizing a caregiver navigator to help them access social support and formal services, which is crucial given the unmet needs of these caregivers.

Preliminary data from the first 15 participants indicate high satisfaction and perceived helpfulness of the intervention, suggesting that caregiver navigation could be an effective model for future support programs in neuro-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing a critical need for caregiver support in neuro-oncology: development of a caregiver navigation intervention using eSNAP social resource visualization. Reblin, M., Wells, KJ., Otto, A., et al.[2022]

A survey of 139 parents of children with brain tumors revealed that unmet informational needs were a significant source of stress across different illness phases, particularly during diagnosis, recurrence, end of life, and remission.

Mothers reported higher stress levels than fathers during adjuvant treatment, indicating a need for targeted support and resources to address the specific concerns of parents during various stages of their child's illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Childhood brain tumors: parental concerns and stressors by phase of illness. Freeman, K., O'Dell, C., Meola, C.[2017]

In a study of 888 brain tumor patients and their relatives, over half of the respondents expressed a strong desire for comprehensive information about their condition, with relatives showing an even higher need for information.

The study found that the need for information increased with the level of education and decreased with the tumor grade, highlighting the importance of tailored communication strategies to meet the specific needs of patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information needs and requirements in patients with brain tumours and their relatives. Reinert, C., Rathberger, K., Klinkhammer-Schalke, M., et al.[2019]

The Cancer Information Service (CIS) effectively supports individuals coping with cancer, with 92% of callers satisfied with the information provided and 95% finding the specialists knowledgeable and trustworthy.

Significant others of cancer patients reported greater satisfaction with the information received compared to the patients themselves, highlighting the need for tailored communication strategies to meet the distinct needs of both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping with cancer: the impact of the Cancer Information Service on patients and significant others. Part 6. Darrow, SL., Speyer, J., Marcus, AC., et al.[2007]

A study involving 173 glioma patients revealed that the highest unmet supportive care needs were in the psychological domain, indicating a significant demand for mental health support among these patients.

Distress was found to be a key factor associated with unmet needs across various domains, suggesting that monitoring distress levels could help neuro-oncologists identify patients who require additional supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with supportive care needs in glioma patients in the neuro-oncological outpatient setting. Renovanz, M., Hechtner, M., Janko, M., et al.[2022]

The establishment of a nurse-led brain tumor support group at Liverpool Hospital has shown to improve outcomes for patients and their caregivers by incorporating a primary healthcare framework.

The success of the support group was attributed to a shift from individual leadership to a collaborative approach, which facilitated ongoing improvements in care throughout the illness trajectory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Primary Healthcare Framework: The Importance of Nursing Leadership in Developing and Maintaining a Brain Tumor Support Group. Nichols, LJ., Wright, KM.[2017]

The I-CoPE supportive care approach for patients with newly diagnosed high-grade glioma was found to be highly acceptable, with 86% enrollment and 88% completion rates among participants, indicating strong feasibility.

After participating in I-CoPE, patients and their carers reported significantly reduced information needs and improved preparedness for caregiving, suggesting preliminary effectiveness in enhancing support, although quality of life did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I-CoPE: A pilot study of structured supportive care delivery to people with newly diagnosed high-grade glioma and their carers. Philip, J., Collins, A., Staker, J., et al.[2022]

A survey of 75 brain tumor patients and 70 carers revealed significant unmet supportive care needs, particularly regarding fatigue, uncertainty about the future, and emotional distress, similar to those seen in other cancer populations.

Patients and carers with higher emotional distress reported greater interest in support services, indicating a need for integrated interventions that address lifestyle, coping strategies, and neuropsychological rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unmet supportive care needs and interest in services among patients with a brain tumour and their carers. Janda, M., Steginga, S., Dunn, J., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Communication, information and support for adults with malignant cerebral glioma : a systematic literature review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Education and psychological support meet the supportive care needs of Taiwanese women three months after surgery for newly diagnosed breast cancer: a non-randomised quasi-experimental study. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Brain cancer patient and support persons' experiences of psychosocial care: a mapping of research outputs. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Informational needs of brain metastases patients and their caregivers. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic review of interventions to improve the provision of information for adults with primary brain tumors and their caregivers. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Addressing a critical need for caregiver support in neuro-oncology: development of a caregiver navigation intervention using eSNAP social resource visualization. [2022]

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

Childhood brain tumors: parental concerns and stressors by phase of illness. [2017]

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

Information needs and requirements in patients with brain tumours and their relatives. [2019]

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

Coping with cancer: the impact of the Cancer Information Service on patients and significant others. Part 6. [2007]

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

Factors associated with supportive care needs in glioma patients in the neuro-oncological outpatient setting. [2022]

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

Implementing a Primary Healthcare Framework: The Importance of Nursing Leadership in Developing and Maintaining a Brain Tumor Support Group. [2017]

12. England pubmed.ncbi.nlm.nih.gov

I-CoPE: A pilot study of structured supportive care delivery to people with newly diagnosed high-grade glioma and their carers. [2022]

13. Ireland pubmed.ncbi.nlm.nih.gov

Unmet supportive care needs and interest in services among patients with a brain tumour and their carers. [2022]