Online Psychosocial Program for Breast Cancer

Overseen By Terry Cheng, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Recurrence, metastatic disease

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate whether an online psychosocial self-help program can help Chinese immigrant women with breast cancer feel more supported and less distressed. It will compare women who use the program to those who do not, focusing on emotional support, self-care, and confidence in returning to normal life. The trial suits foreign-born Chinese women who speak Cantonese or Mandarin, have been diagnosed with early-stage breast cancer (Stages 0-III), and have recently finished surgery or radiation therapy. Participants should also be comfortable using a computer and reading in English, Cantonese, or Mandarin.

As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance support systems for women in similar situations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on Tamoxifen, bisphosphonates, and Herceptin.

What prior data suggests that this online psychosocial program is safe for Chinese immigrant women with breast cancer?

Research has shown that online programs for emotional support are well-received by many, including breast cancer survivors. One study found that a similar program helped reduce stress and improve emotional well-being. Importantly, participants generally did not experience negative side effects, as there were no major reports of harmful effects.

This online self-help program focuses on supporting emotional health, unlike drug treatments that often have side effects. Studies suggest that using online programs for emotional support is safe and can be beneficial for those recovering from breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an innovative way to support breast cancer patients through an online psychosocial self-help program. Unlike traditional in-person therapy or support groups, this program offers the convenience of accessing mental health resources from home, which can be especially beneficial for those with mobility issues or time constraints. Additionally, the program may empower participants to manage their own mental health by providing tools and strategies at their fingertips. This trial could pave the way for more accessible mental health support, potentially improving the overall well-being of breast cancer patients.

What evidence suggests that this online psychosocial program is effective for breast cancer?

Research has shown that online support programs can improve the quality of life for women with breast cancer. Some studies indicate these programs help reduce feelings of depression and anxiety, while also increasing feelings of support and confidence in daily life. In this trial, participants in the Intervention Arm will access an online psychosocial program designed to provide these benefits. Meanwhile, the Control Group will receive standard care without the intervention. Although results can vary, many find these programs beneficial for mental well-being. Overall, these online programs are promising tools for helping breast cancer survivors manage stress and emotional health. ^{1 3 6 7 8}

Who Is on the Research Team?

Terry Cheng

Principal Investigator

Princess Margaret Cancer Centre, University Health Network

Are You a Good Fit for This Trial?

This trial is for foreign-born Chinese immigrant women with a new diagnosis of breast cancer (Stages 0-III). Participants must speak Cantonese or Mandarin as their mother tongue, be receiving surgery or radiation therapy (excluding those on Tamoxifen, bisphosphonates, and Herceptin), and be able to use a computer and read/speak English, Cantonese, or Mandarin. Women with recurrent or metastatic disease cannot participate.

Inclusion Criteria

You were recently diagnosed with early-stage breast cancer.

Women who were born in China and speak Cantonese or Mandarin as their first language.

Able to use a computer

Exclusion Criteria

Your cancer has come back or has spread to other parts of your body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person or virtual)

Intervention

Participants in the intervention arm use the online psychosocial program and complete questionnaires

2 weeks

Online access

Follow-up

Participants complete follow-up questionnaires to assess the impact of the intervention

3 months

Questionnaires administered at 2 weeks and 3 months

Focus Group (optional)

Participants may attend focus groups to discuss their experience with the program

1-1.5 hours

1 session (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Online Psychosocial Self-Help Program

Trial Overview The study tests an online psychosocial program designed for Chinese immigrant women with breast cancer. It aims to see if the program helps them feel supported, understand distress is normal, engage in self-care activities, become aware of community resources, gain confidence in returning to normal life after treatment and reduce overall distress by comparing participants who receive the program against those who do not.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Participants randomized to the Intervention Arm will be provided with the website link to the online psychosocial program and the questionnaire and distress survey. They will be asked to use the website within two weeks and then to complete the questionnaire and distress survey after using it and mail them back in a self-addressed stamped envelope. The participants will also be asked in the 3-month follow-up questionnaire if they are interested in attending a focus group to elaborate on their experience with the psychosocial self-help program. Those who have expressed an interest will be contacted.

Group II: Control Group Experimental Treatment 1 Intervention

Participants randomized to the Control group will receive standard care (no intervention). They will be used as a baseline to compare groups and assess the effect of the intervention (i.e., the online psychosocial program). At the two weeks following randomization (T1) and the 3-month follow-up periods (T2), they will be asked to complete the questionnaire and distress survey and return them in a self-addressed stamped envelope. Participants will be given two weeks to complete the questionnaire and distress survey. The same documents will be administered at the 3-month follow-up period (T2). Once the 3-month follow-up is completed, each participant will be provided with the website link to view the self-help program.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Markham Stouffville Hospital

Collaborator

Trials

4

Recruited

2,500+

Published Research Related to This Trial

A study involving 235 breast cancer patients showed that many had significant psychological distress, with 85% exhibiting comorbid psychopathology, yet 72% were not receiving traditional support.

While online counseling via e-mail did not lead to significant improvements in distress or quality of life compared to a control group, patients reported high satisfaction, indicating that this service may help connect patients to further conventional counseling options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online counseling via e-mail for breast cancer patients on the German internet: preliminary results of a psychoeducational intervention. David, N., Schlenker, P., Prudlo, U., et al.[2021]

The ICOnnecta't digital ecosystem was successfully implemented for women recently diagnosed with breast cancer, showing high acceptance (57.62%) and satisfaction rates (76.19%), which indicates its potential to improve access to psychosocial support.

The platform effectively managed the needs of 443 patients, with 94.33% of users remaining engaged in preventive steps, highlighting the importance of strong social support in improving psychosocial outcomes during the cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ICOnnecta't: Development and Initial Results of a Stepped Psychosocial eHealth Ecosystem to Facilitate Risk Assessment and Prevention of Early Emotional Distress in Breast Cancer Survivors' Journey. Medina, JC., Flix-Valle, A., Rodríguez-Ortega, A., et al.[2022]

A systematic review of 45 studies involving 5400 immigrant and limited English proficient (LEP) cancer patients found that psychosocial interventions had small but positive effects on quality of life and cancer-related distress, with effect sizes of 0.14 for quality of life and 0.14 for distress.

The interventions were primarily focused on Spanish-speaking breast cancer patients, and the overall effect sizes were smaller compared to previous studies on psychosocial interventions for U.S.-born, non-Hispanic White patients, indicating a need for more tailored approaches for immigrant and LEP populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of psychosocial interventions for immigrant and limited English proficient cancer patients. Lui, F., Lewicka, M., Bao, GC., et al.[2023]

The study will evaluate the effectiveness of the online self-help program epos in reducing anxiety and depression symptoms among 325 German-speaking cancer patients transitioning from inpatient to outpatient care.

If successful, epos could provide a valuable, accessible adjunct to traditional face-to-face psycho-oncological support, particularly for patients facing barriers to in-person interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial. Tsiouris, A., Mayer, A., Nölke, C., et al.[2022]

Recent studies indicate that while group therapy does not improve survival rates in advanced breast cancer, it can enhance quality of life and alleviate physical symptoms for patients.

Therapies tailored to specific patient needs are more effective than general approaches, highlighting the importance of therapist experience and training in delivering psychosocial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial interventions for cancer patients. Daniels, J., Kissane, DW.[2008]

A review of 16 studies involving adult cancer patients found that internet-based support programs significantly improve psychosocial and physical symptoms, particularly fatigue, social support, and distress.

All types of online support systems analyzed showed positive effects on quality of life, indicating that these programs can be effective tools for enhancing the well-being of cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based support programs to alleviate psychosocial and physical symptoms in cancer patients: a literature analysis. Bouma, G., Admiraal, JM., de Vries, EG., et al.[2022]

This study will evaluate a new type of online support group for breast cancer survivors that not only provides emotional support but also encourages participants to help others, potentially enhancing psychological benefits.

By comparing a standard online group to a prosocial group that includes structured helping opportunities and coaching, the research aims to determine if this innovative approach can significantly reduce depressive and anxious symptoms while increasing participants' sense of purpose and belonging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial. Lepore, SJ., Buzaglo, JS., Lieberman, MA., et al.[2021]

Internet interventions can effectively address the mental health needs of cancer patients and survivors, helping to fill significant treatment gaps in psychosocial oncology.

Despite the potential, there are currently few rigorous studies on online mental health interventions specifically for cancer patients, highlighting the need for more research and the establishment of best practices in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations. Leykin, Y., Thekdi, SM., Shumay, DM., et al.[2022]

A study involving 114 new members of online self-help groups for breast cancer patients showed significant improvements in depression, personal growth, and psychosocial wellbeing after 6 months.

This research validates the effectiveness of internet bulletin boards as a supportive resource for breast cancer patients, highlighting their accessibility and peer-based support without the need for professional facilitators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-help on-line: an outcome evaluation of breast cancer bulletin boards. Lieberman, MA., Goldstein, BA.[2022]

A 4-week online cognitive-behavioral program for hematologic cancer patients showed a significant increase in fighting spirit compared to a waiting list group, indicating potential efficacy in improving mental adjustment to cancer.

Patient satisfaction with the Internet-based program was high, suggesting that such interventions could be a valuable addition to psychosocial care for cancer patients, although further research is needed to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based program for coping with cancer: a randomized controlled trial with hematologic cancer patients. David, N., Schlenker, P., Prudlo, U., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04656353

Study Details | NCT04656353 | An Impact Assessment of a ... The purpose of the study is to evaluate the effectiveness of an online psychosocial self-help program for Chinese immigrant women with breast cancer, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9157353/

Effectiveness of internet-based support interventions on ... Internet-based support interventions have demonstrated positive effects on women's quality of life and physical variables, but inconsistent effectiveness has ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214782918300794

A guided internet-delivered individually-tailored ACT ... INNOVBC is an internet-delivered ACT-influenced CBT intervention targeting breast cancer survivors. Depression and anxiety are the primary outcomes in this ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9789659/

Finding My Way-Advanced: can a web-based psychosocial ... This study aims to assess its efficacy in improving mental and other QOL domains, distress, fear of progression, unmet needs, and health service utilisation.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0885392417302725

Web-Based Tailored Psychoeducation for Breast Cancer ... The purpose of this multicenter randomized controlled trial was to examine the effectiveness of a web-based tailored psychoeducational program (ENCOURAGE) for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04656353?term=AREA%5BConditionSearch%5D(cancer)%20AND%20AREA%5BBasicSearch%5D(Psychosocial%20Problem)%20AND%20AREA%5BInterventionSearch%5D(Intervention)&rank=10

An Impact Assessment of a Culturally Tailored Online ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11064693/

App-based support for breast cancer patients to reduce ... Efficacy analysis of the primary endpoint revealed a significant reduction in psychological distress (least squares estimate -1.62, 95% ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11942024/

Culturally Sensitive Approaches in Psychosocial Interventions ... Cancer treatment significantly affects the self-efficacy, emotional well-being, and body image of Spanish-speaking breast cancer survivors, and ...