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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Online Psychosocial Self-Help Program, Culturally Tailored Online Psychosocial Program for breast cancer?

Research shows that online self-help groups and bulletin boards for breast cancer patients can significantly improve depression, personal growth, and overall well-being. These online platforms provide accessible support from peers, which can be beneficial for emotional health. ^{1 2 3 4 5}

Is the Online Psychosocial Program for Breast Cancer safe for humans?

The available research on online psychosocial programs for breast cancer patients suggests they are generally safe, with high user satisfaction and no reported safety concerns. These programs have been successfully implemented to support emotional well-being and provide early support pathways. ^{2 4 6 7 8}

How is the Online Psychosocial Self-Help Program for breast cancer different from other treatments?

The Online Psychosocial Self-Help Program is unique because it is a culturally tailored, internet-based intervention that provides accessible psychosocial support specifically for breast cancer patients, focusing on both receiving and giving help in a supportive online community. Unlike traditional in-person therapies, this program leverages the internet to overcome accessibility barriers and offers a flexible, self-directed approach to improving mental well-being. ^{4 5 8 9 10}

What is the purpose of this trial?

The purpose of the study is to evaluate the effectiveness of an online psychosocial self-help program for Chinese immigrant women with breast cancer, by comparing Chinese immigrant women who receive the online psychosocial program and those who do not receive the program. The investigators want to understand if this online psychosocial program is effective in helping Chinese immigrant women to feel more supported, understand that the distress is normal, engage in self-care activities, become aware of the community resources, feel more confident about returning to a normal life, and feel less distress overall as they return to life after treatment. This information will help us to better understand these Chinese immigrant women's needs and concerns and plan future growth of the program to meet their personal, cultural, and language needs.

Research Team

Terry Cheng

Principal Investigator

Princess Margaret Cancer Centre, University Health Network

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

References

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

Internet-based program for coping with cancer: a randomized controlled trial with hematologic cancer patients. [2018]

2. Netherlands 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. [2022]

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

Psychosocial interventions for cancer patients. [2008]

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

Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Self-help on-line: an outcome evaluation of breast cancer bulletin boards. [2022]

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

A systematic review and meta-analysis of psychosocial interventions for immigrant and limited English proficient cancer patients. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Online counseling via e-mail for breast cancer patients on the German internet: preliminary results of a psychoeducational intervention. [2021]

8. Switzerland 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. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Internet-based support programs to alleviate psychosocial and physical symptoms in cancer patients: a literature analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Internet interventions for improving psychological well-being in psycho-oncology: review and recommendations. [2022]