Clinical trial NCT05946993: Linking In With Advice and Supports for Men Impacted by Metastatic Cancer
Official title: Linking In With Advice and Supports for Men Impacted by Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Survivorship
Prostate Cancer
Kidney Cancer
Urothelial Tract/Bladder Cancer, Nos
Testicular Cancer
Penile Cancer
Keywords: cancer
prostate
survivorship
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Irish Cancer Society
name: Cancer Research@UCC
First posted: 2023-07-14
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the feasibility of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary malignancies.

Detailed description: Study design: Sequential Cohorts/ Parallel Sampling Groups Specific Aim: To assess the feasibility of a comprehensive multidisciplinary interventional programme for men living with advanced/metastatic genitourinary cancers Sample size: 72

Entry criteria: Advanced / metastatic genitourinary cancer (including prostate, kidney, urothelial tract, testicular and/or penile cancers), provided they meet the following conditions:

* Prostate cancer - Histologically confirmed prostate cancer and must have commenced Androgen Deprivation Therapy (ADT) in the form of a gonadotropin-releasing hormone (GnRH) analogue or a GnRH receptor antagonist and/or an androgen receptor antagonist and/or undergone bilateral orchidectomy for prostate cancer.
* Urothelial tract cancer - Stage II - IV urothelial tract cancer after completion of primary treatment with systemic therapy
* Kidney cancer - Stage II - III renal cell cancer
* Testicular cancer - Stage II - III testicular cancer after completion of primary treatment
* Penile cancer - • Stage III - IV penile cancer after completion of primary treatment with systemic therapy
* Currently on active surveillance (i.e. no active systemic therapies at present) or continuing on maintenance systemic therapy, provided they do not have ongoing adverse events which will impact their participation at the time of commencing the 12-week intervention.
* Note: Men with resected disease (adjuvant setting) are eligible if they have commenced or completed adjuvant systemic therapy within the past 12 months and have recovered from these treatments at the time of commencing the 12-week programme from ongoing systemic therapy.

Eligibility criteria: Inclusion Criteria:

1. Men aged ≥ 18 years of age at the time of study enrolment.
2. Willing to participate in a 12-week intervention programme and follow up procedures as outlined in the Schedule of Activities section.
3. ECOG performance status 0-2.
4. Recovery to CTCAE Grade ≤2 adverse events from all prior therapies, or adequately recovered adverse events whereby, whereby the PI feels they will not impact the participants ability to complete the 12-week intervention.
5. Disease-specific inclusion criteria:

   Prostate cancer:
   * Histologically confirmed prostate cancer
   * Must have commenced Androgen Deprivation Therapy (ADT) in the form of a gonadotropin-releasing hormone (GnRH) analogue or a GnRH receptor antagonist and/or an androgen receptor antagonist and/or undergone bilateral orchidectomy for prostate cancer. Men must have received last ADT treatment within 12 months of starting the programme or have ongoing treatment-related side effects at the time of commencing the programme if ADT has been discontinued due to toxicity.
   * Patients without histologically confirmed cancer are eligible if both the treating physician and the study PI agree that the patient's history is unambiguously indicative of advanced prostate cancer (e.g. high Prostate-specific antigen (PSA) responsive to ADT in prostate cancer).

   Urothelial tract cancer:
   * Stage II - IV urothelial tract cancer (muscle-invasive, node positive or metastatic disease) after completion of primary treatment with systemic therapy (including in the neoadjuvant or adjuvant setting) and/or surgery and recovery from these treatments to a satisfactory level.
   * Patients with metastatic disease continuing on maintenance systemic therapy are permitted if they do not have ongoing CTCAE Grade \>2 adverse events which will impact their participation at the time of commencing the 12-week programme.

   Kidney cancer:

   • Stage II - III renal cell cancer (clear cell or non-clear cell histologies permitted) after nephrectomy who required and have commenced or completed adjuvant systemic therapy within the past 12 months and have recovered from these treatments to CTCAE Grade ≤2 or do not have ongoing CTCAE Grade \>2 adverse events at the time of commencing the 12-week programme from ongoing systemic therapy.

   Or

   • Stage IV renal cell cancer (clear cell or non-clear cell histologies permitted) where the participants are continuing on stable dose of maintenance systemic therapy and do not have ongoing CTCAE Grade \>2 adverse events at the time of commencing the 12-week programme.

   Testicular cancer:

   • Stage II-III testicular cancer after completion of primary treatment with systemic therapy and/or surgery within the past 12 months and recovery of all adverse events from these treatments to CTCAE Grade ≤2.

   Penile Cancer:
   * Stage III - IV penile cancer (node positive, recurrent or metastatic disease) after completion of primary treatment with systemic therapy (including in the neoadjuvant or adjuvant setting) and/or surgery and recovery from these treatments to CTCAE Grade ≤2.
   * Patients with metastatic disease continuing maintenance systemic therapy are permitted if they do not have ongoing CTCAE Grade \>2 adverse events which will impact their participation at the time of commencing the 12-week programme.
6. Participation in other translational or interventional clinical trials is permitted provided the above disease-specific inclusion criteria are met.
7. Signed consent form by the participant or a legally authorized representative (LAR).

Exclusion Criteria:

1. Persons who, in the opinion of the researcher or supervising clinician, are unable to cooperate adequately with the study protocol, for example those receiving systemic therapy for a concurrent cancer diagnosis, those with organ system dysfunction which would impact their safe participation in the study, or other uncontrolled medical illness that would impact their safe participation in the study.
2. Recent (within 12 months) participation in a study/programme involving a lifestyle intervention (e.g diet, exercise, survivorship).

   1. Note: Per discretion of PI as to whether may impact the outcome of this study intervention.

Primary outcomes:
measure: Feasibility as assessed by a purposefully designed feasibility questionnaire
timeFrame: At week 12
measure: Feasibility as assessed by a purposefully designed feasibility questionnaire
timeFrame: At 6-month post intervention timepoint
measure: The acceptability of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary cancer
timeFrame: At week 12
measure: The acceptability of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary cancer
timeFrame: At the 6-month post intervention timepoint
Secondary outcomes:
measure: Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) scores assessed by European Organization for the Research and Treatment of Cancer (EORTC)
timeFrame: Baseline and at the end of the 12-week programme
measure: Change from Baseline in Fatigue related-Quality of Life Questionnaire (QLQ) scores
timeFrame: Baseline and at the end of the 12-week programme
measure: Change from Baseline in weight.
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in muscle strength and mass.
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in 6-minute walk test.
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in muscle strength scores on handgrip measurements
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in Diet intake scores from multiple 24-hour recalls, complemented by a Food Frequency Questionnaire (FFQ)
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in Diet quality scores from The World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) standardised scoring system (Shams-White et al 2019).
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in BMI scores.
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in Lean Body Mass (LBM) scores.
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in waist circumference scores.
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in Segmental Body Composition scores assessed measured by Body Composition Monitor bioimpedance spectroscopy (BIS).
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Change from Baseline in Nutritional risk scores assessed by the Malnutrition Screening Tool (MST)
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: Self-care agency and its relationship to quality of life and symptoms experienced
timeFrame: Baseline and the programme endpoint (12 weeks).
measure: The resource utilisation of signposted services among participants in the 12-week intervention programme
timeFrame: Baseline and the programme endpoint (12 weeks). A high score represents high functionality problems.
measure: Satisfaction of participants and Health Care Professionals with the programme and their perceptions of the systems usability.
timeFrame: At the programme endpoint (12 weeks)
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
Study officials:
affiliation: Cork University Hospital
name: Jack Gleeson, MB
role: PRINCIPAL_INVESTIGATOR
References: