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Quality of Life in Patients With Anal Cancer (ANCA)

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ClinicalTrials.gov Identifier: NCT02546973
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden

Brief Summary:

A national study of a three year cohort consisting of all patients diagnosed with anal cancer in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. All out- and inpatient visits with diagnoses, admission dates and discharge dates will be requested including.

Patient documentation from the concerned hospitals will be collected and data on the details of the treatment collected retrospectively in a standardised fashion using a clinical record form.

Comorbidity will be calculated using data from the Patient Registry using all main and co-diagnoses 2 years prior and then at least two years after treatment cessation.

Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6 years after index treatment.


Condition or disease
Anal Cancer

Detailed Description:

Squamous cell carcinoma of the anus or "anal cancer" is an uncommon disease in the Western world. In Sweden approximately 100 patients are diagnosed each year. Most patients are treated by chemotherapy and radiation, but a small subgroup of non-responders and patients with recurrent disease undergo abdominoperineal excision with a permanent colostomy. In most reports of results these patients have a worse prognosis and a higher risk of local recurrence than anal cancer as a group(1, 2), possibly a result of a selection bias. Recently the results in a large Nordic cohort were presented, indicating that a further factor connected with successful outcome was that the patient was included in a treatment protocol(3).

A small number of patients with very small cancers are operated on primarily. This is especially true for anal margin tumours(4). However, for the most part patients will be primarily treated with radiotherapy, as their curative treatment.

In Sweden the treatment has been centralised for many years. The radiotherapy is normally a long course therapy with many smaller doses resulting in a high dose of radiation. There are well known complications such as skin problems and to some extent chronic radiation effects on deeper structures, which can result in functional side effects. If the treatment includes an abdominoperineal excision, the effects of a colostomy on quality of life as well as functional aspects of this surgical procedure are largely unknown in this group of patients. In our research group we have earlier studied large cohorts of patients who have undergone abdominoperineal excision for rectal cancer, and also unselected groups of patients with rectal cancer, studying both functional aspects and quality of life using detailed questionnaires (5, 6). Further we have results on quality of life from a cohort of Swedish inhabitants, representing men and women aged 30 to 90 years. The majority of the questions in these questionnaires are similar making comparisons possible.

In other studies within the SSORG network we have used the "Steineck concept" to investigate patient experiences of health, functional results and quality of life (7-11). We use specific questionnaires with detailed questions about experiences and symptoms asking about severity and duration as well as questions on socioeconomic functioning and life style factors (12, 13). Our experience is that patients are motivated to answer such questionnaires, with a compliance at 3 months >90% and at 12 months >85%.


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: ANCA - A Registry Based Study of Clinical Results and Health Related Quality of Life in Patients After Treatment for Anal Cancer
Study Start Date : September 2015
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Group/Cohort
Patients with anal cancer
All patients with anal cancer during 2011-2013 will be asked to participate



Primary Outcome Measures :
  1. HRQL in patient's with anal cancer 3 years after diagnosis [ Time Frame: 3 years ]
    To determine HRQL in patient's with anal cancer 3 years after diagnosis using a thorough questionnaire


Secondary Outcome Measures :
  1. HRQL in patient's with anal cancer 6 years after diagnosis Functional aspects and symptoms [ Time Frame: 6 years ]
    To determine HRQL in patient's with anal cancer 3 years after diagnosis using a thorough questionnaire

  2. Comorbidity in the cohort prior to the diagnosis anal cancer [ Time Frame: 3 years ]
  3. Post-treatment morbidity in patients treated for anal cancer [ Time Frame: 3 years ]
  4. Type and number of surgical procedures in the patient population treated for anal cancer [ Time Frame: 6 years ]
  5. Accumulated length of hospital stay [ Time Frame: 6 years ]
  6. Differences in morbidity related to different treatments regimes [ Time Frame: 3 and 6 yeras ]
  7. Complete health economic analysis of resource consumption [ Time Frame: 6 years ]
  8. Mortality after anal cancer treatment [ Time Frame: 3 and 6 years ]
  9. Patient related personal factors that may affect HRQL measured by questionnaires [ Time Frame: 3 years ]
  10. Effect of complications on the patient's socioeconomic situation [ Time Frame: 3 years ]
  11. HRQL (measured by questionnaires) differences between patient groups such as age, gender and educational level [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with anal cancer diagnosed 2011-2013
Criteria

Inclusion Criteria:

  • All patients registered with a diagnosis of anal cancer in either the Patient registry or the Cancer Registry during 2011 - 2013.

Exclusion Criteria:

  • No informed consent received for participation in the questionnaire part of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546973


Contacts
Contact: Eva Angenete, M.D., Ph.D. eva.angenete@vgregion.se

Locations
Sweden
Dept. of Surgery, Sahlgrenska University Hospital/Ostra Recruiting
Gothenburg, Sweden, SE 416 85
Contact: Eva Angenete, MD,PhD    +46313438410    eva.angenete@vgregion.se   
Contact: Erik         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Eva Angenete, M.D., Ph.D. Sahlgrenska University Hospital, Sweden

Responsible Party: Eva Angenete, M.D., Ph.D., Ass. Prof., Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02546973     History of Changes
Other Study ID Numbers: ANCA
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases