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出境医 / 临床实验 / Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes

Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes

Study Description
Brief Summary:

The investigators plan to investigate the consequences of late effects (radiation-induced survivorship syndromes) after radiotherapy in Gynecological and Prostate cancer survivors on return to work (Yes/No) and if RTW happened then time to RTW.

In addition, whether general health, type of work (occupation), work environment factors, individual factors (lifestyle, socioeconomic status etc.), contribute to the adverse late effects of radiotherapy and these Gynecological cancer survivors have a higher risk for disability pension/long term sickness absence (NOT Return to work).


Condition or disease Intervention/treatment
Gynecologic Cancer Prostate Cancer Radiation Toxicity Malignancy Radiotherapy Side Effect Radiation Injuries Cancer Survivors Radiation Syndrome Radiation: Radiotherapy

Detailed Description:

Occurrence of cancer diagnoses are rising, and both disease and treatments are aggressive. Due to advancement in medical technology, improved therapy and/or early detection the overall survival rates are also improving.

Some of the most common cancer types, such as breast cancer, prostate cancer, cervical cancer, and colorectal cancer have high cure rates when detected early and treated according to best practices. Many of these cancer survivors are of working age and are likely to return to work. Women who survive cervical cancer and men who survive testicular cancer typically have three to four decades left in working life.

However, return to work (RTW) among cancer survivors may not be similar to RTW among long-term sickness absentees due to other diagnoses. Cancer is a life threatening disease and cancer diagnose is a life changing event. The emotional shock after the cancer diagnosis may be associated with low psychological well-being even two years after prostate cancer surgery.

The successful cancer treatment concludes with the lifelong consequences of surgery, irradiation, cytotoxic chemotherapy, biological anticancer substances or other drugs in the treatment. The ionizing radiation that eliminates malignant cells may trigger long-lasting pathophysiological processes in the normal tissue and affect the health of the survivors with lifelong treatment-induced survivorship diseases. In a recent study, Steineck et al, identified five radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer; urgency syndrome (30%), leakage syndrome (26%), excessive gas discharge(15%), excessive mucus discharge (16%) and blood discharge (10%).

There is a lack of knowledge about how these side effects of cancer treatment affect the degree of work ability and return to work. Clinical experience suggests that many cancer survivors have reduced work ability. There is a need for scientific studies that shed light on the side effects of cancer treatment and their relation to work ability.

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 2135 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes
Actual Study Start Date : January 1991
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2016
Arms and Interventions
Group/Cohort Intervention/treatment
Gynecological Cases

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy at

  1. Radiumhemmat, Karolinska University Hospital and
  2. Jubileumskliniken at Sahlgrenska University Hospital in Sweden.
 Radiation: Radiotherapy
Radiotherapy as part of cancer treatment
Prostate Cases
Prostate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden
 Radiation: Radiotherapy
Radiotherapy as part of cancer treatment
Gynecological Rehab Cases
Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy
 Radiation: Radiotherapy
Radiotherapy as part of cancer treatment
Outcome Measures
Primary Outcome Measures :
  1. Return to work (RTW) [ Time Frame: Five - Ten years after mapping Radiation-induced survivorship syndromes ]
    Information on Sickness absence for more than 14 days was obtained from the official registries in Sweden.


Secondary Outcome Measures :
  1. Time to Return to work [ Time Frame: Five - Ten years after mapping Radiation-induced survivorship syndromes ]
    Sickness absence (more than 14 days) until the survivor returned to work. Also obtained from the official registries in Sweden.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gyaecological cancer survivors Prostate cancer survivors
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort of women treated with external pelvic radiotherapy for a gynaecological malignancy and men treated with radiotherapy for prostate cancer at two large oncology clinics in Sweden.
Criteria

Inclusion Criteria:

  1. Age 25 to 60 years (working age)
  2. Employed at time of diagnosis
  3. Treated for cancer
  4. Suffering from at least one of Radiation-induced survivorship syndromes
  5. First cancer & first time treatment for cancer,

Exclusion Criteria:

  1. No other chronic disease
  2. Chronic intestinal illness/surgery
  3. Stage IV cancer
  4. Recurrent cancer/Relapse
Contacts and Locations

Locations
Layout table for location information
Sweden
Jubileumskliniken, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Vastra Gotaland Region
Investigators
Layout table for investigator information
Principal Investigator: Gunnar Steineck Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden
Tracking Information
First Submitted Date May 22, 2019
First Posted Date May 23, 2019
Last Update Posted Date May 28, 2019
Actual Study Start Date January 1991
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2019) 		Return to work (RTW) [ Time Frame: Five - Ten years after mapping Radiation-induced survivorship syndromes ]
Information on Sickness absence for more than 14 days was obtained from the official registries in Sweden.
Original Primary Outcome Measures
 (submitted: May 22, 2019) 		Return to work (RTW) [ Time Frame: Five - Ten years after mapping Radiation-induced survivorship syndromes ]
To explore RTW among cancer survivors presenting treatment induced survivorship syndromes
Change History
Current Secondary Outcome Measures
 (submitted: May 23, 2019) 		Time to Return to work [ Time Frame: Five - Ten years after mapping Radiation-induced survivorship syndromes ]
Sickness absence (more than 14 days) until the survivor returned to work. Also obtained from the official registries in Sweden.
Original Secondary Outcome Measures
 (submitted: May 22, 2019) 		Time to Return to work [ Time Frame: Five - Ten years after mapping Radiation-induced survivorship syndromes ]
The time taken to RTW among cancer survivors with different type of treatment induced survivorship syndromes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes
Official Title Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes
Brief Summary

The investigators plan to investigate the consequences of late effects (radiation-induced survivorship syndromes) after radiotherapy in Gynecological and Prostate cancer survivors on return to work (Yes/No) and if RTW happened then time to RTW.

In addition, whether general health, type of work (occupation), work environment factors, individual factors (lifestyle, socioeconomic status etc.), contribute to the adverse late effects of radiotherapy and these Gynecological cancer survivors have a higher risk for disability pension/long term sickness absence (NOT Return to work).
Detailed Description

Occurrence of cancer diagnoses are rising, and both disease and treatments are aggressive. Due to advancement in medical technology, improved therapy and/or early detection the overall survival rates are also improving.

Some of the most common cancer types, such as breast cancer, prostate cancer, cervical cancer, and colorectal cancer have high cure rates when detected early and treated according to best practices. Many of these cancer survivors are of working age and are likely to return to work. Women who survive cervical cancer and men who survive testicular cancer typically have three to four decades left in working life.

However, return to work (RTW) among cancer survivors may not be similar to RTW among long-term sickness absentees due to other diagnoses. Cancer is a life threatening disease and cancer diagnose is a life changing event. The emotional shock after the cancer diagnosis may be associated with low psychological well-being even two years after prostate cancer surgery.

The successful cancer treatment concludes with the lifelong consequences of surgery, irradiation, cytotoxic chemotherapy, biological anticancer substances or other drugs in the treatment. The ionizing radiation that eliminates malignant cells may trigger long-lasting pathophysiological processes in the normal tissue and affect the health of the survivors with lifelong treatment-induced survivorship diseases. In a recent study, Steineck et al, identified five radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer; urgency syndrome (30%), leakage syndrome (26%), excessive gas discharge(15%), excessive mucus discharge (16%) and blood discharge (10%).

There is a lack of knowledge about how these side effects of cancer treatment affect the degree of work ability and return to work. Clinical experience suggests that many cancer survivors have reduced work ability. There is a need for scientific studies that shed light on the side effects of cancer treatment and their relation to work ability.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cohort of women treated with external pelvic radiotherapy for a gynaecological malignancy and men treated with radiotherapy for prostate cancer at two large oncology clinics in Sweden.
Condition
  • Gynecologic Cancer
  • Prostate Cancer
  • Radiation Toxicity
  • Malignancy
  • Radiotherapy Side Effect
  • Radiation Injuries
  • Cancer Survivors
  • Radiation Syndrome
Intervention Radiation: Radiotherapy
Radiotherapy as part of cancer treatment
Study Groups/Cohorts
  • Gynecological Cases

    Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy at

    1. Radiumhemmat, Karolinska University Hospital and
    2. Jubileumskliniken at Sahlgrenska University Hospital in Sweden.
    Intervention: Radiation: Radiotherapy
  • Prostate Cases
    Prostate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden
    Intervention: Radiation: Radiotherapy
  • Gynecological Rehab Cases
    Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy
    Intervention: Radiation: Radiotherapy
Publications *
  • Steineck G, Skokic V, Sjöberg F, Bull C, Alevronta E, Dunberger G, Bergmark K, Wilderäng U, Oh JH, Deasy JO, Jörnsten R. Identifying radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer survivors. PLoS One. 2017 Feb 3;12(2):e0171461. doi: 10.1371/journal.pone.0171461. eCollection 2017.
  • Dunberger G, Lind H, Steineck G, Waldenström AC, Nyberg T, Al-Abany M, Nyberg U, Vall-Lundqvist E. Self-reported symptoms of faecal incontinence among long-term gynaecological cancer survivors and population-based controls. Eur J Cancer. 2010 Feb;46(3):606-15. doi: 10.1016/j.ejca.2009.10.023. Epub 2009 Nov 18.
  • Alsadius D, Hedelin M, Johansson KA, Pettersson N, Wilderäng U, Lundstedt D, Steineck G. Tobacco smoking and long-lasting symptoms from the bowel and the anal-sphincter region after radiotherapy for prostate cancer. Radiother Oncol. 2011 Dec;101(3):495-501. doi: 10.1016/j.radonc.2011.06.010. Epub 2011 Jul 5.
  • Lind H, Waldenström AC, Dunberger G, al-Abany M, Alevronta E, Johansson KA, Olsson C, Nyberg T, Wilderäng U, Steineck G, Åvall-Lundqvist E. Late symptoms in long-term gynaecological cancer survivors after radiation therapy: a population-based cohort study. Br J Cancer. 2011 Sep 6;105(6):737-45. doi: 10.1038/bjc.2011.315. Epub 2011 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 22, 2019) 		2135
Original Actual Enrollment Same as current
Actual Study Completion Date December 2016
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age 25 to 60 years (working age)
  2. Employed at time of diagnosis
  3. Treated for cancer
  4. Suffering from at least one of Radiation-induced survivorship syndromes
  5. First cancer & first time treatment for cancer,

Exclusion Criteria:

  1. No other chronic disease
  2. Chronic intestinal illness/surgery
  3. Stage IV cancer
  4. Recurrent cancer/Relapse
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Gyaecological cancer survivors Prostate cancer survivors
Ages 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03961217
Other Study ID Numbers ANB_691-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gunnar Steineck, Sahlgrenska University Hospital, Sweden
Study Sponsor Sahlgrenska University Hospital, Sweden
Collaborators Vastra Gotaland Region
Investigators
Principal Investigator: Gunnar Steineck Clinical Cancer Epidemiology, Sahlgrenska Academy, Gothenburg, Sweden
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date May 2019

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