Quality of Life Interventions for Colon Cancer

Recruiting at3 trial locations

Overseen by Kevin D Cassel, Dr. PH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Hawaii

Disqualifiers: Over 60 days post-surgery

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial provides colon cancer patients and their caregivers with tablets containing helpful information about the disease and its treatment. Regular support and surveys aim to reduce anxiety, improve communication with doctors, and enhance overall care.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It seems to focus on providing information and support rather than altering your treatment plan.

What data supports the effectiveness of the treatment Quality of Life Supportive Resources, Supportive Care, Palliative Care, Psychosocial Support, Quality of Life Ted Talks for improving quality of life in colon cancer patients?

Research shows that psychosocial interventions can improve the quality of life for colorectal cancer patients, and supportive care interventions have been linked to better overall well-being. Additionally, palliative care has been shown to help manage symptoms and improve quality of life in advanced cancer patients. ^{1 2 3 4 5}

Is the Quality of Life Interventions for Colon Cancer treatment safe for humans?

Research on supportive care interventions, such as psychosocial support and decision aids, shows they are generally safe for cancer patients, providing emotional support and helpful information without causing distress. ^{6 7 8 9 10}

How does the treatment for improving quality of life in colon cancer patients differ from other treatments?

This treatment focuses on psychosocial interventions, which aim to improve the quality of life for colon cancer patients by addressing emotional and social needs, unlike traditional treatments that primarily target the physical aspects of the disease. ^{1 5 11 12 13}

Research Team

Kevin D Cassel, Dr. PH

Principal Investigator

University of Hawaii Cancer Research Center

Eligibility Criteria

This trial is for adult colon cancer patients and their caregivers in Honolulu County. Patients must be newly diagnosed with stage II-III colon cancer, within 60 days post-surgery, and able to understand and write English. Caregivers can be family or someone the patient identifies as a caregiver.

Inclusion Criteria

I am a caregiver living in Honolulu, over 18, speak and write English, and can consent.

Patient: Colon Cancer patients must live in Honolulu County and must identify a patient caregiver. Patients must have newly diagnosed stage II-III colon cancer and be < 60 days from surgical treatment at the time of registration. Adults over age 18. Adequate understanding of English language and must be able to read and write English. Must be able to provide informed consent.

Exclusion Criteria

I had surgery less than 60 days ago.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants and caregivers receive educational materials and support resources via computer tablets to improve quality of life and care coordination.

12 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for changes in quality of life and care coordination perceptions after the intervention.

4 weeks

Treatment Details

Interventions

• Quality of Life Supportive Resources (Behavioral)
• Quality of Life Ted Talks (Behavioral)

Trial Overview The study provides educational resources about colon cancer via tablets to improve quality of life for patients and caregivers. It includes weekly check-ins from the study team, use of information provided on tablets, and completing surveys assessing its impact.

Participant Groups

Group I: Group A Experimental Treatment 1 Intervention

Ted Talks/Educational videos

Group II: Group 1 Experimental Treatment 1 Intervention

Supportive Care Materials and Resources

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

Robert J. Robinson

University of Hawaii

Chief Executive Officer since 2001

PhD from Stanford University

Enrique J. Carrazana

University of Hawaii

Chief Medical Officer since 2023

MD from Harvard Medical School

Alliance for Clinical Trials in Oncology

Collaborator

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

Findings from Research

In a study involving 98 advanced colorectal cancer patients undergoing chemotherapy, an integrated psychosocial intervention led to significant improvements in patients' adaptation and awareness, as well as a notable decrease in anxiety levels after 18 weeks.

Patients reported a positive impact on their health-related quality of life (HRQOL) and care quality, indicating that incorporating psychological support into medical treatment is feasible and beneficial, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated psychological strategy for advanced colorectal cancer patients. Pugliese, P., Perrone, M., Nisi, E., et al.[2019]

Recent studies on supportive care interventions in palliative settings have started to measure overall benefits, not just symptom improvement, highlighting a shift towards evaluating quality of life.

Some palliative chemotherapy studies showed measurable improvements in overall well-being, while certain supportive care approaches were linked to significant declines in health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of supportive care in quality of life. Warr, D., Feld, R.[2019]

In a multicenter study involving 571 advanced cancer patients, significant functional impairments and increased symptoms like fatigue and emotional distress were noted in the last two weeks of life, highlighting the challenges in managing quality of life during this period.

The study suggests that quality of life assessments in palliative care should account for varying responses to interventions across different quality of life components, indicating the need for tailored approaches in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality of life at the end of life. Analysis of the quality of life of oncologic patients treated with palliative care. Results of a multicenter observational study (staging)]. Miccinesi, G., Paci, E., Toscani, F., et al.[2022]

Quality of life (QOL) is a crucial patient-related outcome measure in surgical oncology, alongside traditional metrics like mortality and survival rates, as it helps identify overlooked physical or psychological issues that can affect patient care.

The review highlights the importance of incorporating well-validated QOL assessment tools in clinical trials for gastrointestinal cancers, such as esophageal, pancreatic, and colorectal cancers, to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical perspectives in gastrointestinal disease: a study of quality of life outcomes in esophageal, pancreatic, colon, and rectal cancers. Viola, KV., Ariyan, C., Sosa, JA.[2019]

Only three out of fourteen randomized controlled trials (RCTs) showed significant positive effects of psychosocial interventions on mental health outcomes for colorectal cancer (CRC) patients, indicating limited efficacy overall.

The interventions that were effective included emotional expression techniques and progressive muscle relaxation, but many other psychoeducational and supportive care interventions showed little to no impact, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of psychosocial interventions for colorectal cancer patients. Mosher, CE., Winger, JG., Given, BA., et al.[2018]

The SCAN trial is a randomized controlled study involving 370 adults with colorectal cancer, aiming to assess the impact of specialized oncology nurse support on health-related quality of life (HRQoL) after hospital discharge.

Patients receiving nurse-led interventions, which include symptom monitoring and self-management counseling, are expected to experience improved HRQoL compared to those receiving standard care, addressing significant unmet supportive care needs in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN). Bauer, A., Vordermark, D., Seufferlein, T., et al.[2019]

A pilot study involving eight colorectal cancer patients receiving chemotherapy showed that a psychoeducational intervention improved their quality of life and communication with healthcare providers.

Participants reported satisfaction with the emotional support and medical information received during the four biweekly telephone sessions, indicating the intervention's feasibility and potential benefits for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive telephone intervention for patients receiving chemotherapy. A pilot study. Alter, CL., Fleishman, SB., Kornblith, AB., et al.[2004]

In a study involving 80 colorectal cancer patients, a multidisciplinary support system, including telephone support, was evaluated for its impact on adverse events and quality of life during CapeOX therapy.

The incidence of hand-foot syndrome (HFS) exceeding grade 2 was 16.3% overall, with a lower rate of 11.1% in patients receiving telephone support, suggesting that such support may help reduce this common side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Observational Study of Team Management Approach for CapeOX Therapy in Patients with Advanced and Recurrent Colorectal Cancer: SMILE Study (The Study of Metastatic colorectal cancer to investigate the Impact of Learning Effect). Matsuoka, H., Ogata, Y., Nakamura, M., et al.[2022]

A decision aid developed for patients with advanced cancers helped reduce misconceptions about the possibility of cure and the benefits of palliative chemotherapy, with 52% initially believing in curability dropping to 31% after using the aid.

The intervention was well-received, with 74% of patients finding the information helpful and 93% wanting to share it with their family and doctors, indicating that discussing prognosis and treatment options can be done without causing distress or diminishing hope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of decision aids to give truthful prognostic and treatment information to chemotherapy patients with advanced cancer. Smith, TJ., Dow, LA., Virago, EA., et al.[2023]

Patients with advanced pancreatic cancer have limited treatment options that provide only marginal survival benefits, such as chemotherapy that may extend life by about 9 weeks compared to best supportive care, but most patients will not survive beyond 24 months.

Effective communication about prognosis is crucial, as only one-third of cancer patients are informed about their terminal status, leading to poorer medical outcomes; oncologists can improve this by using clear information and decision aids during discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explaining marginal benefits to patients, when "marginal" means additional but not necessarily small. Smith, TJ., Hillner, BE.[2010]

Psychosocial support for cancer patients is crucial for enhancing their quality of life by addressing not only emotional distress but also managing cancer symptoms and treatment side effects.

Interventions can be categorized into five types: prevention, early detection, restoration, support, and palliation, each tailored to meet the varying needs of patients throughout their cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychiatrist's perspective on quality of life and quality of care in oncology: concepts, symptom management, communication issues. Razavi, D., Delvaux, N.[2019]

A systematic review of 12 studies involving 3,390 cancer patients and their caregivers found that psychosocial interventions significantly improve quality of life, particularly through telephone-based support and interpersonal counseling.

The review highlighted a need for more comprehensive interventions that also address spiritual well-being, which has been largely overlooked in existing studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of psychosocial interventions to improve quality of life of people with cancer and their family caregivers. Gabriel, I., Creedy, D., Coyne, E.[2021]

Family-based psychosocial interventions for advanced cancer patients can significantly enhance the quality of life for both patients and their caregivers, but few randomized controlled trials have been conducted to support this in clinical practice.

Existing interventions are often not well integrated into routine palliative care, highlighting the need for more comprehensive programs that address both patient and family needs in advanced cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial Interventions for Patients With Advanced Cancer and Their Families. Badr, H.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

An integrated psychological strategy for advanced colorectal cancer patients. [2019]

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

The role of supportive care in quality of life. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

[Quality of life at the end of life. Analysis of the quality of life of oncologic patients treated with palliative care. Results of a multicenter observational study (staging)]. [2022]

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

Surgical perspectives in gastrointestinal disease: a study of quality of life outcomes in esophageal, pancreatic, colon, and rectal cancers. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

A systematic review of psychosocial interventions for colorectal cancer patients. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN). [2019]

7. England pubmed.ncbi.nlm.nih.gov

Supportive telephone intervention for patients receiving chemotherapy. A pilot study. [2004]

8. Japan pubmed.ncbi.nlm.nih.gov

An Observational Study of Team Management Approach for CapeOX Therapy in Patients with Advanced and Recurrent Colorectal Cancer: SMILE Study (The Study of Metastatic colorectal cancer to investigate the Impact of Learning Effect). [2022]

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

A pilot trial of decision aids to give truthful prognostic and treatment information to chemotherapy patients with advanced cancer. [2023]

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

Explaining marginal benefits to patients, when "marginal" means additional but not necessarily small. [2010]

11. England pubmed.ncbi.nlm.nih.gov

The psychiatrist's perspective on quality of life and quality of care in oncology: concepts, symptom management, communication issues. [2019]

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

A systematic review of psychosocial interventions to improve quality of life of people with cancer and their family caregivers. [2021]

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

Psychosocial Interventions for Patients With Advanced Cancer and Their Families. [2020]