Quality of Life Interventions for Colon Cancer

Not currently recruiting at 3 trial locations

Overseen By Aaron Roberts

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: Over 60 days post-surgery

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the quality of life for people with colon cancer and their caregivers by providing educational resources and support. Participants will receive a tablet to access information about colon cancer, including videos and materials designed to reduce anxiety and improve communication with healthcare teams. The trial is open to those newly diagnosed with stage II or III colon cancer in Honolulu County who have had surgery within the last 60 days. Caregivers must also live in Honolulu County and be able to understand and communicate in English. Participants will provide feedback through surveys, and their insights will help refine these Quality of Life Supportive Resources. This unphased trial offers a unique opportunity to contribute to the development of valuable resources that can enhance patient and caregiver experiences.

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 prior data suggests that these quality of life interventions are safe for colon cancer patients and their caregivers?

Research shows that supportive resources and educational videos can improve the emotional and mental well-being of people with colon cancer. Studies have found that these tools enhance quality of life by offering emotional support and personalized information.

For example, research on supportive care materials indicates they significantly improve the well-being of patients with colorectal cancer. These resources reduce stress and increase patients' understanding of their condition. Similarly, educational videos, such as Ted Talks, provide valuable information about colon cancer risks and prevention strategies, helping patients feel more in control of their health.

Importantly, these interventions are generally safe. No reports of negative effects from using educational videos or supportive resources exist. Participants engage with information and support tools, which are non-invasive and carry no physical risk. The main commitment is time, as patients are encouraged to use these resources regularly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for colon cancer because they focus on enhancing patients' quality of life, which is often overlooked by standard medical treatments. Unlike chemotherapy or surgery, which directly target cancer cells, these new interventions use educational videos and supportive care materials. This approach aims to empower patients with knowledge and resources, potentially reducing stress and improving overall well-being. By addressing the emotional and psychological aspects of living with cancer, these treatments offer a holistic complement to traditional care, providing support that could lead to a more positive patient experience.

What evidence suggests that this trial's interventions could improve quality of life for colon cancer patients?

Studies have shown that emotional support and personalized help can greatly improve the quality of life for patients with colorectal cancer. Research indicates that mental and social support positively affects both emotional well-being and overall life satisfaction for these patients. In this trial, one group of participants will receive supportive care materials and resources to meet patients' needs and improve their healthcare experiences, leading to better quality of life. Another group will access educational content, such as TED Talks, to raise awareness about colon cancer and provide valuable information on prevention and care. These tools aim to enhance understanding and support around colon cancer treatment, easing the journey for patients and their caregivers. ^{1 6 7 8 9}

Who Is on the Research Team?

Kevin D Cassel, Dr. PH

Principal Investigator

University of Hawaii Cancer Research Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Quality of Life Supportive Resources
• Quality of Life Ted Talks

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.

How Is the Trial Designed?

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+

Alliance for Clinical Trials in Oncology

Collaborator

Trials

521

Recruited

224,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988287/

Psychological Distress and Quality of Life in Patients with ... This study reinforces the critical role of emotional support and personalized interventions in improving QoL for patients with colorectal cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5540437/

A Systematic Review of Psychosocial Interventions for ... The goal of this systematic review was to assess the impact of psychosocial interventions on quality-of-life and psychosocial outcomes for CRC patients.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002074891930241X

Identifying associations between quality of life outcomes ... This study explores associations between colorectal cancer survivors' healthcare experiences and quality of life.

4. biomedcentral.com biomedcentral.com/collections/qolc

Quality of life and supportive care in cancer This Collection aims showcases research that explores the integration of palliative care, technology-enabled supportive care, and personalized approaches.

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1166801/full

Supportive care needs and health-related quality of life in ... The first objective of this study was to analyze the SCNs in cancer patients receiving palliative care, and to explore the relationship between ...

6. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1437888/full

Supportive care needs, quality of life and social ... Supportive care needs, quality of life and social support among elderly colorectal cancer patients undergoing chemotherapy: a longitudinal study.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6881415/

Supportive care needs of patients following treatment for ... To investigate unmet needs of patients with colorectal cancer (CRC) at the end of treatment and whether unmet needs improve over time.

8. tandfonline.com tandfonline.com/doi/full/10.1080/28352610.2023.2279094

The future of supportive care interventions for colorectal ... Respondents (87.2%) identified that establishing clinical pathways would better facilitate ongoing care for CRC survivors and 61.3% recognized the potential for ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.24.00542

Palliative Care for Patients With Cancer: ASCO Guideline ... These studies demonstrated that early referral to specialized palliative care of patients with advanced cancer led to improved QOL, mood (as a ...