TEMPO Program for Prostate Cancer

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help men with prostate cancer and their caregivers manage physical and emotional challenges. It tests an online tool called TEMPO, which provides guidance on coping skills and exercise. Participants will either use TEMPO or monitor their anxiety for 12 weeks, with the option to access TEMPO later if needed. This trial suits men diagnosed with prostate cancer who experience moderate anxiety, have a caregiver willing to participate, and have internet access. As an unphased trial, it offers participants the chance to contribute to research that may enhance support tools for managing cancer-related anxiety.

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 prior data suggests that the TEMPO program is safe for men with prostate cancer and their caregivers?

Research has shown that the TEMPO program helps men with prostate cancer and their caregivers manage physical and emotional challenges. This online program allows patients and caregivers to use it independently. Studies have examined the acceptance and usage of TEMPO.

Specific information about safety risks, such as side effects, is not available. However, as an online program rather than a medication or surgery, it is generally considered low risk. Participants have reported positive outcomes, including better communication and improved coping skills. As a web-based tool, TEMPO is expected to be user-friendly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TEMPO Program for prostate cancer because it introduces a flexible, stepped care approach that adjusts to each patient's needs. Unlike traditional treatments that might rely solely on medication or surgery, TEMPO offers variations in timing and intensity, allowing for a more personalized experience. The program combines self-directed and guided interventions, empowering patients and caregivers to actively participate in managing their anxiety alongside usual care. This innovative approach aims to enhance patient outcomes by tailoring support to individual circumstances, potentially improving both mental and physical health.

What evidence suggests that the TEMPO program is effective for prostate cancer?

Research has shown that the TEMPO program, which participants in this trial may receive, is designed to help men with prostate cancer and their caregivers manage physical and emotional challenges. Past participants reported improved communication and coping skills, along with increased physical activity. The program is online and interactive, offering support without the need for a healthcare professional. Based on evidence from previous cancer support studies, it aims to reduce anxiety and improve overall health. Users found it practical and helpful, suggesting it effectively meets the needs of those affected by prostate cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Sylvie Lambert, PhD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7980105/

A study protocol for a multicenter randomized pilot trial of a ... TEMPO is a 10-week, interactive, web-based intervention consisting of five modules designed to help dyads manage their physical and psychosocial needs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8871005/

Feasibility, Acceptability, and Clinical Significance of a ... TEMPO is an evidence-informed program designed for men with prostate cancer and their caregivers (as a dyad) to learn self-management skills based on their ...

3. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1584764/pdf

Effectiveness of mobile health in symptom management of ... Studies have shown that the incidence of urinary incontinence among localized prostate cancer was 4%–31%, the incidence of fecal incontinence ...

4. withpower.com withpower.com/trial/phase-prostate-cancer-8-2024-19ddb

TEMPO Program for Prostate Cancer The research highlights that more intensive systemic treatments for metastatic castration-sensitive prostate cancer can improve survival and quality of life, ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/5/e082709

a systematic review and meta-analysis protocol 3 Research has indicated that patients with prostate cancer can achieve positive survival outcomes through surgical interventions, radiation therapy, ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-01382

Effect of Mindfulness for Prostatectomy Outcomes, ... This clinical trial develops and examines a mindfulness program intended to reduce distress for men with prostate cancer undergoing radical prostatectomy ...

7. researchgate.net researchgate.net/publication/358313145_Feasibility_Acceptability_and_Clinical_Significance_of_a_Dyadic_Web-Based_Psychosocial_and_Physical_Activity_Self-Management_Program_TEMPO_Tailored_to_the_Needs_of_Men_with_Prostate_Cancer_and_Their_C

(PDF) Feasibility, Acceptability, and Clinical Significance of ... The purpose of this study was to pilot TEMPO—the first dyadic, Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram ...