TEMPO Program for Prostate Cancer

Recruiting at 1 trial location

Overseen By Sylvie Lambert, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Mary's Research Center, Canada

Disqualifiers: Hospitalized

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

Compensation: Varies

Number of Visits: 1

376 Participants Needed

Trial Summary

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 to focus on a web-based program for managing anxiety and physical activity, so it's unlikely that medication changes are required.

What data supports the effectiveness of the TEMPO treatment for prostate cancer?

The research highlights that more intensive systemic treatments for metastatic castration-sensitive prostate cancer can improve survival and quality of life, suggesting that similar approaches might be beneficial. However, specific data on the TEMPO treatment's effectiveness is not provided. ^{1 2 3 4 5}

What safety data exists for the TEMPO Program for Prostate Cancer treatment?

The safety of treatments involving testosterone therapy and combinations like paclitaxel, estramustine phosphate, and carboplatin has been studied in prostate cancer patients, focusing on risks of recurrence and adverse events. These studies suggest that while there are risks, such treatments have been evaluated for safety in humans. ^{6 7 8 9 10}

How does the TEMPO treatment for prostate cancer differ from other treatments?

The TEMPO treatment for prostate cancer may involve a unique approach that includes exercise training, which has been shown to improve physical condition and quality of life in patients undergoing androgen deprivation therapy (ADT). This differs from traditional treatments by focusing on supervised exercise to counteract the adverse effects of ADT, such as fatigue and cardiovascular risks. ^{11 12 13 14 15}

What is the purpose of this trial?

Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatment(s), which often lead to high anxiety. The pandemic has highlighted the importance of protecting our physical and mental health, and the complex responsibilities that caregivers have in supporting their loved ones. To improve the health of men with prostate cancer and of their caregivers, the research team developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. TEMPO was developed with men with prostate cancer and their caregivers over the past 8 years. It also combines the investigators' research conducted over the past decade on providing the best support to those affected by cancer. Because the cancer care workforce is already overstretched, the research team designed TEMPO to be used without guidance from a health care professional. TEMPO is one-of-a kind in its support of both patients and caregivers, and the integration of coping skills training on a wide range of cancer challenges along with a home-based exercise program. Patients and caregivers who have used TEMPO said they improved their communication, learned new skills to cope with both physical and emotional challenges of cancer, and increased their physical activity. The present project builds on this work to further evaluate the cost and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will be identified based on an assessment of their anxiety level. For those already using TEMPO and needing more support, non-health care professional guidance might be offered. All those in the monitoring group needing more support will now have access to TEMPO. All participants complete surveys to determine whether TEMPO led to improved health outcomes.

Research Team

Sylvie Lambert, PhD

Principal Investigator

McGill University

Eligibility Criteria

This trial is for men with prostate cancer and their caregivers. It's designed to help them manage the emotional and physical challenges of cancer without needing a healthcare professional. Participants will use TEMPO, a web-based program offering coping skills training and exercise routines.

Inclusion Criteria

One member of the dyad has anxiety symptoms

Patients and caregivers need to be able to read English or French

I have been treated for prostate cancer, not just monitored, in the last 2 years.

Exclusion Criteria

Either member of the dyad is hospitalized at recruitment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Initial Treatment

Participants are randomized to either TEMPO self-directed or active monitoring of anxiety for 12 weeks

12 weeks

Online engagement with TEMPO or monitoring

Re-randomization and Continued Treatment

Participants needing more support are re-randomized to TEMPO with guidance or continue with TEMPO self-directed; active monitoring group offered TEMPO

12 weeks

Online engagement with potential guidance

Follow-up

Participants are monitored for anxiety and other health outcomes post-treatment

4 weeks

Surveys and assessments

Treatment Details

Interventions

• TEMPO

Trial Overview TEMPO, a self-management program for prostate cancer patients and their caregivers, is being tested against simply monitoring anxiety levels over 12 weeks. The study aims to see if TEMPO improves health outcomes without professional guidance.

Participant Groups

Group I: TEMPO Experimental Treatment 1 Intervention

Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). All dyads will continue to access usual care (a co-intervention measure is included).

Group II: Actively Monitoring dyads' anxiety Active Control 1 Intervention

Patients will receive usual care throughout the study.

Who Is Running the Clinical Trial?

St. Mary's Research Center, Canada

Lead Sponsor

Trials

11

Recruited

1,800+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Simon Fraser University

Collaborator

Trials

59

Recruited

12,500+

Université de Sherbrooke

Collaborator

Trials

317

Recruited

79,300+

Findings from Research

Quality of life (QOL) data from patient-reported outcome measures (PROMs) is crucial for men undergoing androgen deprivation therapy (ADT) for prostate cancer, as it helps inform treatment decisions and regulatory approvals.

Studies indicate that while more intensive systemic treatments for metastatic castration-sensitive prostate cancer (mCSPC) improve survival, they also enhance QOL, highlighting the need for rigorous QOL assessments in clinical trials of new ADT approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported Outcomes in Metastatic Castration-sensitive Prostate Cancer in the Adjuvant Setting. Morgans, AK., Stockler, MR.[2020]

In a study of 213 prostate cancer patients, those receiving androgen deprivation therapy (ADT) alongside radiation therapy (RT) reported significantly lower scores in sexual function and hormonal vitality compared to those receiving RT alone, indicating a negative impact on quality of life.

Factors such as lower education levels and the presence of depression further worsened the quality of life scores, highlighting the need for targeted support and interventions for patients undergoing combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Androgen Deprivation Therapy on Sexual and Hormonal Function in Patients Receiving Radiation Therapy for Prostate Cancer. Kushnir, T., Gofrit, ON., Elkayam, R., et al.[2016]

The RAVES trial is a phase III study involving 470 patients with pT3 prostate cancer, comparing early salvage radiotherapy (SRT) triggered by rising PSA levels to standard adjuvant radiotherapy (ART) given within 4 months after surgery.

As of October 2013, 258 patients have been randomized, and the trial aims to determine if observation with early SRT is as effective as ART in preventing biochemical failure, with additional assessments on patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy -- Adjuvant Versus Early Salvage (RAVES) trial. Pearse, M., Fraser-Browne, C., Davis, ID., et al.[2022]

In a study of 69,984 men with localized prostate cancer, testosterone therapy (TT) after treatment did not increase the risk of biochemical recurrence or mortality, indicating its safety for patients post-treatment.

Among the 469 men who received TT after surgery and 543 after radiation, there were no significant differences in cancer-specific or overall mortality compared to those who did not receive TT, suggesting that TT can be safely administered to appropriate patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone therapy does not increase the risks of prostate cancer recurrence or death after definitive treatment for localized disease. Sarkar, RR., Patel, SH., Parsons, JK., et al.[2021]

In a review of 21 randomized controlled trials involving 9040 patients with nonmetastatic prostate cancer, it was found that acute adverse events (AEs) were primarily reported by clinicians, while patient-reported outcomes (PROs) were underutilized, especially for late AEs.

The study highlights a gap in incorporating patient perspectives in reporting AEs related to radical radiation therapy, suggesting a need for standardized PRO assessments to better capture patient experiences and improve treatment evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials. Holch, P., Henry, AM., Davidson, S., et al.[2022]

Testosterone therapy (TTh) can significantly improve the quality of life for men, and concerns about it increasing the risk of prostate cancer or cardiovascular issues are not strongly supported by current evidence.

While the safety of TTh in men with a history of prostate cancer remains uncertain, existing data does not convincingly show that TTh causes or worsens prostate cancer, suggesting that it may be considered for treating hypogonadal men with such a history, albeit with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Testosterone Therapy in the Setting of Prostate Cancer. Rodriguez, KM., Pastuszak, AW., Khera, M.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-reported Outcomes in Metastatic Castration-sensitive Prostate Cancer in the Adjuvant Setting. [2020]

2. Israel pubmed.ncbi.nlm.nih.gov

Impact of Androgen Deprivation Therapy on Sexual and Hormonal Function in Patients Receiving Radiation Therapy for Prostate Cancer. [2016]

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

Patient-perceived satisfaction after definitive treatment for men with high-risk prostate cancer: radical prostatectomy vs. intensity-modulated radiotherapy with androgen deprivation therapy. [2015]

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

A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy -- Adjuvant Versus Early Salvage (RAVES) trial. [2022]

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

Survival benefit of local versus no local treatment for metastatic prostate cancer-Impact of baseline PSA and metastatic substages. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

The Danish Prostate Cancer Database. [2020]

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

Testosterone therapy does not increase the risks of prostate cancer recurrence or death after definitive treatment for localized disease. [2021]

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

Multicenter phase 2 study of neoadjuvant paclitaxel, estramustine phosphate, and carboplatin plus androgen deprivation before radiation therapy in patients with unfavorable-risk localized prostate cancer: results of Cancer and Leukemia Group B 99811. [2015]

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

Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials. [2022]

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

Outcomes of a Dose-Escalated Stereotactic Body Radiation Phase 1 Trial for Patients With Low- and Intermediate-Risk Prostate Cancer. [2019]

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

A multi-centre investigation of delivering national guidelines on exercise training for men with advanced prostate cancer undergoing androgen deprivation therapy in the UK NHS. [2022]

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

Intermittent use of testosterone inactivating pharmaceuticals using finasteride prolongs the time off period. [2022]

13. China pubmed.ncbi.nlm.nih.gov

A systematic review evaluating the effectiveness of exercise training on physical condition in prostate cancer patients undergoing androgen deprivation therapy. [2023]

14. Poland pubmed.ncbi.nlm.nih.gov

Inflammation, cardiometabolic markers, and functional changes in men with prostate cancer. A randomized controlled trial of a 12‑month exercise program. [2022]

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

The Role of Testosterone Therapy in the Setting of Prostate Cancer. [2018]